Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation "BRAIN-AF"

Recruiting

Phase 3 Results N/A

Update History

12 Dec '15
The eligibility criteria were updated.
New
For entry into the study, the following criteria MUST be met: Inclusion Criteria: - Age at consent ≥30 to ≤60 years - Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing (routine 12-lead electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker or implantable cardiac defibrillator interrogation of at least 30 s) within the prior 12 months - Low risk of stroke as defined by the absence of all of the following: i. Prior stroke or Transient Ischemic Attack , ii. Hypertension, iii. Diabetes mellitus, iv. Congestive heart failure (New York Heart Association class II or higher at the time of enrolment or a known left ventricular ejection fraction <35%); - Signed written informed consent For entry into the study, none of the following criteria MUST be met Exclusion Criteria: - Known diagnosis of dementia; - Valvular AF (Clinically significant (severe or moderate) rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or mitral valve repair) or hypertrophic cardiomyopathy; - Other indication for antiplatelet therapy or anticoagulation; - History of GI bleeding; - Conditions associated with an increased risk of bleeding described as follows: 1. Major surgery within the previous month; 2. Planned surgery or intervention within the next 3 months; 3. History of intracranial, intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding; 4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days; 5. Haemorrhagic disorder or bleeding diathesis; 6. Fibrinolytic agents within 48 hours of study entry; 7. Recent malignancy or radiation therapy (within 6 months from the time of enrolment) and not expected to survive 3 years; - Reversible cause of AF (e.g. cardiac surgery, pulmonary embolism, untreated hyperthyroidism); - Plan to perform pulmonary vein ablation or surgery for treatment of AF; - Absence of recurrence of AF 3 months after AF ablation; - Severe renal impairment (creatinine clearance 30 mL/min or less); - Active infective endocarditis; - Active liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine Transaminase (ALT) >3 times the upper limit of normal; - Women who are pregnant or of childbearing potential not using a medically acceptable form of contraception throughout the study; - Women who are breast feeding; - Anemia or thrombocytopenia (according to the normal range values of the local laboratory); - Investigational drug received in the past 30 days; - Subjects considered unreliable, or having a life expectancy of less than 3 years or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse); - Known diagnosis of major depression within the past year.
Old
For entry into the study, the following criteria MUST be met: Inclusion Criteria: - Age at consent ≥30 to ≤60 years - Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing (routine 12-lead electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker or implantable cardiac defibrillator interrogation of at least 30 s) within the prior 12 months - Low risk of stroke as defined by the absence of all of the following: i. Prior stroke or Transient Ischemic Attack , ii. Hypertension, iii. Diabetes mellitus, iv. Congestive heart failure (New York Heart Association class II or higher at the time of enrolment or a known left ventricular ejection fraction <35%); - Signed written informed consent For entry into the study, none of the following criteria MUST be met Exclusion Criteria: - Known diagnosis of dementia; - Valvular AF (Clinically significant (severe or moderate) rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or mitral valve repair) or hypertrophic cardiomyopathy; - Other indication for antiplatelet therapy or anticoagulation; - History of GI bleeding; - Conditions associated with an increased risk of bleeding described as follows: 1. Major surgery within the previous month; 2. Planned surgery or intervention within the next 3 months; 3. History of intracranial, intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding; 4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days; 5. Haemorrhagic disorder or bleeding diathesis; 6. Fibrinolytic agents within 48 hours of study entry; 7. Recent malignancy or radiation therapy (within 6 months from the time of enrolment) and not expected to survive 3 years; - Reversible cause of AF (e.g. cardiac surgery, pulmonary embolism, untreated hyperthyroidism); - Plan to perform pulmonary vein ablation or surgery for treatment of AF; - Absence of recurrence of AF 3 months after AF ablation; - Severe renal impairment (creatinine clearance 30 mL/min or less); - Active infective endocarditis; - Active liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine Transaminase (ALT) >3 times the upper limit of normal; - Women who are pregnant or of childbearing potential not using a medically acceptable form of contraception throughout the study; - Women who are breast feeding; - Anemia or thrombocytopenia (according to the normal range values of the local laboratory); - Investigational drug received in the past 30 days; - Subjects considered unreliable, or having a life expectancy of less than 3 years or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse); - Known diagnosis of major depression within the past year.
7 May '15
A location was updated in Montreal.
New
The overall status was updated to "Recruiting" at Montreal Heart Institute.