NCT00262600CompletedPhase 3
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Boehringer Ingelheim984 sites in 1 country18,113 target enrollmentStarted: December 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 18,113
- Locations
- 984
- Primary Endpoint
- Yearly Event Rate for Composite Endpoint of Stroke/SEE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dabigatran dose 2
Active Comparator
twice a day
Intervention: Dabigatran dose 2 (Drug)
Warfarin
Active Comparator
once a day
Intervention: warfarin (Drug)
Dabigatran dose 1
Active Comparator
twice a day
Intervention: Dabigatran dose 1 (Drug)
Outcomes
Primary Outcomes
Yearly Event Rate for Composite Endpoint of Stroke/SEE
Time Frame: 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 Outcomes
- Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death(36 months)
- Bleeding Events (Major and Minor)(36 months)
- Abnormal Liver Function Test(36 months)
- Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death(36 months)
- Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)(36 months)
Investigators
Study Sites (984)
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