A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

Completed

Phase 4 Results

Update History

6 Oct '15
The Summary of Purpose was updated.
New
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
Old
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
The eligibility criteria were updated.
New
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 4. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 5. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 6. Need for anticoagulant treatment for disorders other than atrial fibrillation 7. Current treatment with rifampin 8. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) 9. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 10. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 11. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 12. Any condition the investigator believes would not allow safe participation in the study 13. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
Old
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. not applicable 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study 14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
19 Nov '14
The eligibility criteria were updated.
New
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. not applicable 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study 14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
Old
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. NA 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study 14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
2 May '14
A location was updated in Birmingham.
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The overall status was removed for 1160.128.1046 Boehringer Ingelheim Investigational Site.
A location was updated in Huntsville.
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The overall status was removed for 1160.128.1045 Boehringer Ingelheim Investigational Site.
A location was updated in Mobile.
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The overall status was removed for 1160.128.1003 Boehringer Ingelheim Investigational Site.
A location was updated in Chandler.
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The overall status was removed for 1160.128.1093 Boehringer Ingelheim Investigational Site.
A location was updated in Hot Springs.
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The overall status was removed for 1160.128.1067 Boehringer Ingelheim Investigational Site.
A location was updated in Mesa.
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The overall status was removed for 1160.128.1103 Boehringer Ingelheim Investigational Site.
A location was updated in Newport Beach.
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The overall status was removed for 1160.128.1094 Boehringer Ingelheim Investigational Site.
A location was updated in San Diego.
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The overall status was removed for 1160.128.1042 Boehringer Ingelheim Investigational Site.
A location was updated in Colorado Spring.
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The overall status was removed for 1160.128.1005 Boehringer Ingelheim Investigational Site.
A location was updated in Denver.
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The overall status was removed for 1160.128.1023 Boehringer Ingelheim Investigational Site.
A location was updated in Bridgeport.
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The overall status was removed for 1160.128.1016 Boehringer Ingelheim Investigational Site.
A location was updated in Bridgeport.
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The overall status was removed for 1160.128.1066 Boehringer Ingelheim Investigational Site.
A location was updated in Guilford.
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The overall status was removed for 1160.128.1018 Boehringer Ingelheim Investigational Site.
A location was updated in Norwalk.
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The overall status was removed for 1160.128.1050 Boehringer Ingelheim Investigational Site.
A location was updated in Waterbury.
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The overall status was removed for 1160.128.1057 Boehringer Ingelheim Investigational Site.
A location was updated in Washington.
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The overall status was removed for 1160.128.1085 Boehringer Ingelheim Investigational Site.
A location was updated in Atlantis.
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The overall status was removed for 1160.128.1111 Boehringer Ingelheim Investigational Site.
A location was updated in Brandon.
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The overall status was removed for 1160.128.1032 Boehringer Ingelheim Investigational Site.
A location was updated in Coral Springs.
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The overall status was removed for 1160.128.1021 Boehringer Ingelheim Investigational Site.
A location was updated in Daytona Beach.
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The overall status was removed for 1160.128.1027 Boehringer Ingelheim Investigational Site.
A location was updated in Jacksonville.
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The overall status was removed for 1160.128.1062 Boehringer Ingelheim Investigational Site.
A location was updated in Jacksonville.
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The overall status was removed for 1160.128.1019 Boehringer Ingelheim Investigational Site.
A location was updated in Largo.
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The overall status was removed for 1160.128.1054 Boehringer Ingelheim Investigational Site.
A location was updated in Miami.
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The overall status was removed for 1160.128.1097 Boehringer Ingelheim Investigational Site.
A location was updated in Miami.
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The overall status was removed for 1160.128.1109 Boehringer Ingelheim Investigational Site.
A location was updated in Orlando.
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The overall status was removed for 1160.128.1087 Boehringer Ingelheim Investigational Site.
A location was updated in Pensacola.
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The overall status was removed for 1160.128.1058 Boehringer Ingelheim Investigational Site.
A location was updated in Port Charlotte.
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The overall status was removed for 1160.128.1007 Boehringer Ingelheim Investigational Site.
A location was updated in Rockledge.
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The overall status was removed for 1160.128.1060 Boehringer Ingelheim Investigational Site.
A location was updated in Columbus.
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The overall status was removed for 1160.128.1096 Boehringer Ingelheim Investigational Site.
A location was updated in Roswell.
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The overall status was removed for 1160.128.1068 Boehringer Ingelheim Investigational Site.
A location was updated in Coeur d' Alene.
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The overall status was removed for 1160.128.1076 Boehringer Ingelheim Investigational Site.
A location was updated in Melrose Park.
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The overall status was removed for 1160.128.1073 Boehringer Ingelheim Investigational Site.
A location was updated in Winfield.
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The overall status was removed for 1160.128.1048 Boehringer Ingelheim Investigational Site.
A location was updated in Hammond.
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The overall status was removed for 1160.128.1105 Boehringer Ingelheim Investigational Site.
A location was updated in Indianapolis.
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The overall status was removed for 1160.128.1029 Boehringer Ingelheim Investigational Site.
A location was updated in Overland Park.
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The overall status was removed for 1160.128.1079 Boehringer Ingelheim Investigational Site.
A location was updated in Baton Rouge.
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The overall status was removed for 1160.128.1008 Boehringer Ingelheim Investigational Site.
A location was updated in Auburn.
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The overall status was removed for 1160.128.1025 Boehringer Ingelheim Investigational Site.
A location was updated in Biddeford.
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The overall status was removed for 1160.128.1100 Boehringer Ingelheim Investigational Site.
A location was updated in Columbia.
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The overall status was removed for 1160.128.1041 Boehringer Ingelheim Investigational Site.
A location was updated in Salisbury.
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The overall status was removed for 1160.128.1012 Boehringer Ingelheim Investigational Site.
A location was updated in Rochester Hills.
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The overall status was removed for 1160.128.1015 Boehringer Ingelheim Investigational Site.
A location was updated in Tupelo.
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The overall status was removed for 1160.128.1004 Boehringer Ingelheim Investigational Site.
A location was updated in Columbia.
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The overall status was removed for 1160.128.1014 Boehringer Ingelheim Investigational Site.
A location was updated in Kansas City.
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The overall status was removed for 1160.128.1047 Boehringer Ingelheim Investigational Site.
A location was updated in St. Louis.
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The overall status was removed for 1160.128.1075 Boehringer Ingelheim Investigational Site.
A location was updated in Great Falls.
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The overall status was removed for 1160.128.1069 Boehringer Ingelheim Investigational Site.
A location was updated in Kalispell.
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The overall status was removed for 1160.128.1011 Boehringer Ingelheim Investigational Site.
A location was updated in Lincoln.
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The overall status was removed for 1160.128.1092 Boehringer Ingelheim Investigational Site.
A location was updated in Omaha.
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The overall status was removed for 1160.128.1059 Boehringer Ingelheim Investigational Site.
A location was updated in Elmer.
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The overall status was removed for 1160.128.1039 Boehringer Ingelheim Investigational Site.
A location was updated in Flemington.
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The overall status was removed for 1160.128.1035 Boehringer Ingelheim Investigational Site.
A location was updated in Albuquerque.
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The overall status was removed for 1160.128.1036 Boehringer Ingelheim Investigational Site.
A location was updated in Hawthorne.
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The overall status was removed for 1160.128.1063 Boehringer Ingelheim Investigational Site.
A location was updated in Mineola.
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The overall status was removed for 1160.128.1078 Boehringer Ingelheim Investigational Site.
A location was updated in Poughkeepsie.
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The overall status was removed for 1160.128.1001 Boehringer Ingelheim Investigational Site.
A location was updated in Asheville.
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The overall status was removed for 1160.128.1022 Boehringer Ingelheim Investigational Site.
A location was updated in Gastonia.
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The overall status was removed for 1160.128.1052 Boehringer Ingelheim Investigational Site.
A location was updated in Statesville.
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The overall status was removed for 1160.128.1071 Boehringer Ingelheim Investigational Site.
A location was updated in Gallipolis.
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The overall status was removed for 1160.128.1091 Boehringer Ingelheim Investigational Site.
A location was updated in Oklahoma City.
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The overall status was removed for 1160.128.1107 Boehringer Ingelheim Investigational Site.
A location was updated in Bend.
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The overall status was removed for 1160.128.1053 Boehringer Ingelheim Investigational Site.
A location was updated in Hillsboro.
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The overall status was removed for 1160.128.1033 Boehringer Ingelheim Investigational Site.
A location was updated in Altoona.
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The overall status was removed for 1160.128.1037 Boehringer Ingelheim Investigational Site.
A location was updated in Camp Hill.
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The overall status was removed for 1160.128.1034 Boehringer Ingelheim Investigational Site.
A location was updated in Langhorne.
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The overall status was removed for 1160.128.1010 Boehringer Ingelheim Investigational Site.
A location was updated in Pittsburgh.
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The overall status was removed for 1160.128.1056 Boehringer Ingelheim Investigational Site.
A location was updated in Uniontown.
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The overall status was removed for 1160.128.1065 Boehringer Ingelheim Investigational Site.
A location was updated in Charleston.
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The overall status was removed for 1160.128.1043 Boehringer Ingelheim Investigational Site.
A location was updated in Rapid City.
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The overall status was removed for 1160.128.1040 Boehringer Ingelheim Investigational Site.
A location was updated in Houston.
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The overall status was removed for 1160.128.1104 Boehringer Ingelheim Investigational Site.
A location was updated in Killeen.
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The overall status was removed for 1160.128.1006 Boehringer Ingelheim Investigational Site.
A location was updated in McKinney.
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The overall status was removed for 1160.128.1061 Boehringer Ingelheim Investigational Site.
A location was updated in New Braunfels.
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The overall status was removed for 1160.128.1090 Boehringer Ingelheim Investigational Site.
A location was updated in San Antonio.
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The overall status was removed for 1160.128.1082 Boehringer Ingelheim Investigational Site.
A location was updated in Layton.
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The overall status was removed for 1160.128.1102 Boehringer Ingelheim Investigational Site.
A location was updated in Danville.
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The overall status was removed for 1160.128.1077 Boehringer Ingelheim Investigational Site.
A location was updated in Falls Church.
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The overall status was removed for 1160.128.1064 Boehringer Ingelheim Investigational Site.
A location was updated in Manassas.
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The overall status was removed for 1160.128.1110 Boehringer Ingelheim Investigational Site.
A location was updated in Norfolk.
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The overall status was removed for 1160.128.1099 Boehringer Ingelheim Investigational Site.
A location was updated in Calgary.
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The overall status was removed for 1160.128.1160 Boehringer Ingelheim Investigational Site.
A location was updated in Edmonton.
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The overall status was removed for 1160.128.1159 Boehringer Ingelheim Investigational Site.
A location was updated in Red Deer.
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The overall status was removed for 1160.128.1152 Boehringer Ingelheim Investigational Site.
A location was updated in Spruce Grove.
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The overall status was removed for 1160.128.1153 Boehringer Ingelheim Investigational Site.
A location was updated in Coquitlam.
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The overall status was removed for 1160.128.1167 Boehringer Ingelheim Investigational Site.
A location was updated in Victoria.
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The overall status was removed for 1160.128.1158 Boehringer Ingelheim Investigational Site.
A location was updated in Saint John.
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The overall status was removed for 1160.128.1154 Boehringer Ingelheim Investigational Site.
A location was updated in Bay Roberts.
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The overall status was removed for 1160.128.1166 Boehringer Ingelheim Investigational Site.
A location was updated in Brampton.
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The overall status was removed for 1160.128.1151 Boehringer Ingelheim Investigational Site.
A location was updated in Cambridge.
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The overall status was removed for 1160.128.1168 Boehringer Ingelheim Investigational Site.
A location was updated in Collingwood.
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The overall status was removed for 1160.128.1164 Boehringer Ingelheim Investigational Site.
A location was updated in Corunna.
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The overall status was removed for 1160.128.1173 Boehringer Ingelheim Investigational Site.
A location was updated in Hamilton.
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The overall status was removed for 1160.128.1156 Boehringer Ingelheim Investigational Site.
A location was updated in Kitchener.
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The overall status was removed for 1160.128.1157 Boehringer Ingelheim Investigational Site.
A location was updated in London.
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The overall status was removed for 1160.128.1155 Boehringer Ingelheim Investigational Site.
A location was updated in Peterborough.
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The overall status was removed for 1160.128.1170 Boehringer Ingelheim Investigational Site.
A location was updated in Sarnia.
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The overall status was removed for 1160.128.1165 Boehringer Ingelheim Investigational Site.
A location was updated in Sarnia.
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The overall status was removed for 1160.128.1169 Boehringer Ingelheim Investigational Site.
A location was updated in Stayner.
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The overall status was removed for 1160.128.1161 Boehringer Ingelheim Investigational Site.
A location was updated in Sudbury.
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The overall status was removed for 1160.128.1171 Boehringer Ingelheim Investigational Site.
A location was updated in Toronto.
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The overall status was removed for 1160.128.1162 Boehringer Ingelheim Investigational Site.
A location was updated in Saskatoon.
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The overall status was removed for 1160.128.1172 Boehringer Ingelheim Investigational Site.
4 Apr '14
A location was updated in Atlantis.
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The overall status was removed for 1160.128.1111 Boehringer Ingelheim Investigational Site.
21 Mar '14
A location was updated in Orlando.
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The overall status was removed for 1160.128.1087 Boehringer Ingelheim Investigational Site.
A location was updated in Tupelo.
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The overall status was removed for 1160.128.1004 Boehringer Ingelheim Investigational Site.
7 Feb '14
A location was updated in Daytona Beach.
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The overall status was removed for 1160.128.1027 Boehringer Ingelheim Investigational Site.
A location was updated in Miami.
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The overall status was removed for 1160.128.1109 Boehringer Ingelheim Investigational Site.
A location was updated in Bend.
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The overall status was removed for 1160.128.1053 Boehringer Ingelheim Investigational Site.
A location was updated in Killeen.
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The overall status was removed for 1160.128.1006 Boehringer Ingelheim Investigational Site.
A location was updated in Manassas.
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The overall status was removed for 1160.128.1110 Boehringer Ingelheim Investigational Site.
A location was updated in Corunna.
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The overall status was removed for 1160.128.1173 Boehringer Ingelheim Investigational Site.
20 Dec '13
The Summary of Purpose was updated.
New
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
Old
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 12 months prior to enrolment. Approximately 60 - 80 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
The eligibility criteria were updated.
New
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. NA 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study 14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
Old
Inclusion criteria: 1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent Exclusion criteria: 1. History within one year of any of the following gastrointestinal (GI) disorders: dyspepsia, abdominal pain or discomfort, heartburn, indigestion, nausea, vomiting, gastritis, gastroesophageal reflux, or of use of proton pump inhibitors, histamine-2 receptor blockers or antacids. 2. GI bleeding within the past 2 years unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. Any history of symptomatic or endoscopically documented gastroduodenal ulcer, or diverticulitis 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance <15ml/min, or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study
A location was updated in Washington.
New
The overall status was removed for 1160.128.1085 Boehringer Ingelheim Investigational Site.
A location was updated in Biddeford.
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The overall status was removed for 1160.128.1100 Boehringer Ingelheim Investigational Site.
A location was updated in Columbia.
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The overall status was removed for 1160.128.1041 Boehringer Ingelheim Investigational Site.
A location was updated in St. Louis.
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The overall status was removed for 1160.128.1075 Boehringer Ingelheim Investigational Site.
A location was updated in Lincoln.
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The overall status was removed for 1160.128.1092 Boehringer Ingelheim Investigational Site.
19 Apr '13
A location was updated in Chandler.
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The overall status was removed for 1160.128.1093 Boehringer Ingelheim Investigational Site.
A location was updated in Norfolk.
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The overall status was removed for 1160.128.1099 Boehringer Ingelheim Investigational Site.
5 Apr '13
A location was updated in Columbus.
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The overall status was removed for 1160.128.1096 Boehringer Ingelheim Investigational Site.
A location was updated in Gallipolis.
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The overall status was removed for 1160.128.1091 Boehringer Ingelheim Investigational Site.
A location was updated in Austin.
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The overall status was updated to "Recruiting" at 1160.128.1098 Boehringer Ingelheim Investigational Site.
22 Mar '13
A location was updated in New Braunfels.
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The overall status was removed for 1160.128.1090 Boehringer Ingelheim Investigational Site.
A location was updated in Segiun.
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The overall status was updated to "Recruiting" at 1160.128.1089 Boehringer Ingelheim Investigational Site.
8 Mar '13
A location was updated in Newport Beach.
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The overall status was removed for 1160.128.1094 Boehringer Ingelheim Investigational Site.
A location was updated in Bridgeport.
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The overall status was removed for 1160.128.1066 Boehringer Ingelheim Investigational Site.
A location was updated in Miami.
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The overall status was removed for 1160.128.1097 Boehringer Ingelheim Investigational Site.
A location was updated in Erie.
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The overall status was updated to "Recruiting" at 1160.128.1072 Boehringer Ingelheim Investigational Site.
8 Feb '13
A location was updated in Coeur d' Alene.
New
The overall status was removed for 1160.128.1076 Boehringer Ingelheim Investigational Site.
A location was updated in Omaha.
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The overall status was removed for 1160.128.1059 Boehringer Ingelheim Investigational Site.
A location was updated in San Antonio.
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The overall status was removed for 1160.128.1082 Boehringer Ingelheim Investigational Site.
11 Jan '13
A location was updated in Hawthorne.
New
The overall status was removed for 1160.128.1063 Boehringer Ingelheim Investigational Site.
14 Dec '12
A location was updated in Jacksonville.
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The overall status was removed for 1160.128.1062 Boehringer Ingelheim Investigational Site.
A location was updated in Jacksonville.
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The overall status was removed for 1160.128.1019 Boehringer Ingelheim Investigational Site.
A location was updated in Orlando.
New
The overall status was removed for 1160.128.1087 Boehringer Ingelheim Investigational Site.
A location was updated in Melrose Park.
New
The overall status was removed for 1160.128.1073 Boehringer Ingelheim Investigational Site.
A location was updated in Mineola.
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The overall status was removed for 1160.128.1078 Boehringer Ingelheim Investigational Site.
A location was updated in New York.
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The overall status was updated to "Recruiting" at 1160.128.1083 Boehringer Ingelheim Investigational Site.
A location was updated in McKinney.
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The overall status was removed for 1160.128.1061 Boehringer Ingelheim Investigational Site.
16 Nov '12
A location was updated in Overland Park.
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The overall status was removed for 1160.128.1079 Boehringer Ingelheim Investigational Site.
A location was updated in Charleston.
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The overall status was removed for 1160.128.1043 Boehringer Ingelheim Investigational Site.
A location was updated in Danville.
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The overall status was removed for 1160.128.1077 Boehringer Ingelheim Investigational Site.
19 Oct '12
A location was updated in San Diego.
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The overall status was removed for 1160.128.1042 Boehringer Ingelheim Investigational Site.
A location was updated in Pensacola.
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The overall status was removed for 1160.128.1058 Boehringer Ingelheim Investigational Site.
A location was updated in Great Falls.
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The overall status was removed for 1160.128.1069 Boehringer Ingelheim Investigational Site.
A location was updated in Gastonia.
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The overall status was removed for 1160.128.1052 Boehringer Ingelheim Investigational Site.
A location was updated in Statesville.
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The overall status was removed for 1160.128.1071 Boehringer Ingelheim Investigational Site.
A location was updated in Falls Church.
New
The overall status was removed for 1160.128.1064 Boehringer Ingelheim Investigational Site.
21 Sep '12
A location was updated in Hot Springs.
New
The overall status was removed for 1160.128.1067 Boehringer Ingelheim Investigational Site.
A location was updated in Coral Springs.
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The overall status was removed for 1160.128.1021 Boehringer Ingelheim Investigational Site.
A location was updated in Rockledge.
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The overall status was removed for 1160.128.1060 Boehringer Ingelheim Investigational Site.
A location was updated in Roswell.
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The overall status was removed for 1160.128.1068 Boehringer Ingelheim Investigational Site.
A location was updated in Winfield.
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The overall status was removed for 1160.128.1048 Boehringer Ingelheim Investigational Site.
A location was updated in Baton Rouge.
New
The overall status was removed for 1160.128.1008 Boehringer Ingelheim Investigational Site.
A location was updated in Kansas City.
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The overall status was removed for 1160.128.1047 Boehringer Ingelheim Investigational Site.
A location was updated in Uniontown.
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The overall status was removed for 1160.128.1065 Boehringer Ingelheim Investigational Site.
24 Aug '12
A location was updated in Waterbury.
New
The overall status was removed for 1160.128.1057 Boehringer Ingelheim Investigational Site.
A location was updated in Largo.
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The overall status was removed for 1160.128.1054 Boehringer Ingelheim Investigational Site.
27 Jul '12
A location was updated in Birmingham.
New
The overall status was removed for 1160.128.1046 Boehringer Ingelheim Investigational Site.
A location was updated in Bridgeport.
New
The overall status was removed for 1160.128.1016 Boehringer Ingelheim Investigational Site.
A location was updated in Pittsburgh.
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The overall status was removed for 1160.128.1056 Boehringer Ingelheim Investigational Site.
A location was updated in Rapid City.
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The overall status was removed for 1160.128.1040 Boehringer Ingelheim Investigational Site.
29 Jun '12
A location was updated in Huntsville.
New
The overall status was removed for 1160.128.1045 Boehringer Ingelheim Investigational Site.
A location was updated in Norwalk.
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The overall status was removed for 1160.128.1050 Boehringer Ingelheim Investigational Site.
A location was updated in Muskegon.
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The overall status was updated to "Recruiting" at 1160.128.1017 Boehringer Ingelheim Investigational Site.
A location was updated in Elmer.
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The overall status was removed for 1160.128.1039 Boehringer Ingelheim Investigational Site.
A location was updated in Flemington.
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The overall status was removed for 1160.128.1035 Boehringer Ingelheim Investigational Site.
A location was updated in Albuquerque.
New
The overall status was removed for 1160.128.1036 Boehringer Ingelheim Investigational Site.
A location was updated in Bend.
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The overall status was removed for 1160.128.1053 Boehringer Ingelheim Investigational Site.
4 May '12
A location was updated in Colorado Spring.
New
The overall status was removed for 1160.128.1005 Boehringer Ingelheim Investigational Site.
A location was updated in Port Charlotte.
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The overall status was removed for 1160.128.1007 Boehringer Ingelheim Investigational Site.
A location was updated in Tupelo.
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The overall status was removed for 1160.128.1004 Boehringer Ingelheim Investigational Site.
A location was updated in Ashebille.
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The overall status was updated to "Recruiting" at 1160.128.1022 Boehringer Ingelheim Investigational Site.
A location was updated in Altoona.
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The overall status was removed for 1160.128.1037 Boehringer Ingelheim Investigational Site.
A location was updated in Killeen.
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The overall status was removed for 1160.128.1006 Boehringer Ingelheim Investigational Site.
8 Mar '12
A location was updated in Denver.
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The overall status was removed for 1160.128.1023 Boehringer Ingelheim Investigational Site.
A location was updated in Guilford.
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The overall status was removed for 1160.128.1018 Boehringer Ingelheim Investigational Site.
A location was updated in Brandon.
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The overall status was removed for 1160.128.1032 Boehringer Ingelheim Investigational Site.
A location was updated in Daytona Beach.
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The overall status was removed for 1160.128.1027 Boehringer Ingelheim Investigational Site.
A location was updated in Indianapolis.
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The overall status was removed for 1160.128.1029 Boehringer Ingelheim Investigational Site.
A location was updated in Salisbury.
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The overall status was removed for 1160.128.1012 Boehringer Ingelheim Investigational Site.
A location was updated in Rochester Hills.
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The overall status was removed for 1160.128.1015 Boehringer Ingelheim Investigational Site.
A location was updated in Hillsboro.
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The overall status was removed for 1160.128.1033 Boehringer Ingelheim Investigational Site.
A location was updated in Camp Hill.
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The overall status was removed for 1160.128.1034 Boehringer Ingelheim Investigational Site.
10 Feb '12
A location was updated in Mobile.
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The overall status was removed for 1160.128.1003 Boehringer Ingelheim Investigational Site.
A location was updated in Columbia.
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The overall status was removed for 1160.128.1014 Boehringer Ingelheim Investigational Site.
2 Feb '12
A location was updated in Auburn.
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The overall status was removed for 1160.128.1025 Boehringer Ingelheim Investigational Site.
A location was updated in Kalispell.
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The overall status was removed for 1160.128.1011 Boehringer Ingelheim Investigational Site.
A location was updated in Langhorne.
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The overall status was removed for 1160.128.1010 Boehringer Ingelheim Investigational Site.