At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 18,113 enrolled
Drug / intervention
warfarin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating warfarin, Dabigatran dose 1, and 1 other intervention for Atrial Fibrillation and Stroke. Completed, enrolled 18,113 participants across 984 sites in 44 countries.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPopulation Health Research Institute, Uppsala University
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedDec 2005
Primary CompletionApr 2009
TodayJul 2026
First PostedDec 7, 2005
Enrollment StartDec 1, 2005
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.6 years ago
Interventions
warfarindrug
once a day
Dabigatran dose 1drug
twice daily
Dabigatran dose 2drug
twice a day