THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS) "THAWS"

Recruiting

Phase 3 Results N/A

Update History

7 Apr '17
The gender criteria for eligibility was updated to "All."
5 Apr '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥2 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185 mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator
Old
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥2 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185 mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator
3 Sep '15
The eligibility criteria were updated.
New
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥2 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185 mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator
Old
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours and <12 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥5 and ≤25 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185 mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator
9 Jul '14
A location was updated in Suita.
New
The overall status was updated to "Recruiting" at National Cerebral and Cardiovascular Center.
7 Dec '13
Trial name was updated.
New
THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS)
The eligibility criteria were updated.
New
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours and <12 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥5 and ≤25 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185 mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator
Old
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset) - Last known well without neurological symptoms >4.5 hours and <12 hours of treatment initiation - Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking) - Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed - Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more - No marked parenchymal hyperintensity visible on FLAIR - Initial NIHSS ≥5 and ≤25 - Written informed consent by patient or next of kin Exclusion Criteria: - Pre-stroke mRS >1 (patients who have inability to carry out all daily activities and require some help or supervision) - Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase) - History of nontraumatic intracranial hemorrhage - History of stroke within the last 1 month (excluding transient ischemic attack) - History of significant head/spinal injury or surgery within the last 3 months - History of gastrointestinal or urinary tract bleeding within the last 21 days - History of major surgery or significant trauma other than head injury within the last 14 days - Hypersensitivity to alteplase - Suspected subarachnoid hemorrhage - Concurrent acute aortic dissection - Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis) - Systolic blood pressure ≥185mmHg despite antihypertensive therapy - Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy - Significant hepatic disorder - Acute pancreatitis - Blood glucose <50mg/dL or >400 mg/dL - Platelet count ≤100,000/mm3 - PT-INR >1.7 or Prolonged aPTT (>1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation - Any contraindication to MRI (e.g. cardiac pacemaker) - Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum) - Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques) - Pregnant, lactating, or potentially pregnant - Life expectancy 6 months or less by judgment of the investigator - Inappropriate for study enrollment by judgment of the investigator