Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
- Conditions
- Atrial FibrillationStroke
- Interventions
- Registration Number
- NCT00262600
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran dose 2 Dabigatran dose 2 twice a day Dabigatran dose 1 Dabigatran dose 1 twice a day Warfarin warfarin once a day
- Primary Outcome Measures
Name Time Method Yearly Event Rate for Composite Endpoint of Stroke/SEE 36 months Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
- Secondary Outcome Measures
Name Time Method Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death 36 months Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Bleeding Events (Major and Minor) 36 months Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Major bleeds are adjudicated, whereas minor bleeds are investigator reported.Abnormal Liver Function Test 36 months Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST\>3xULN and total bilirubin \> 2 x ULN
Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death 36 months Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) 36 months Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)
Related Research Topics
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Trial Locations
- Locations (984)
1160.26.0009 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.26.0046 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.26.0057 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.26.0211 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.26.0206 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
1160.26.0115 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
1160.26.0104 Boehringer Ingelheim Investigational Site
🇺🇸Lake Havasu City, Arizona, United States
1160.26.0304 Boehringer Ingelheim Investigational Site
🇺🇸Peoria, Arizona, United States
1160.26.0185 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
1160.26.0305 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
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