Cardiovascular Atlas
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RE-LY

A large trial that compared two doses of the blood thinner dabigatran with warfarin in people with atrial fibrillation at risk of stroke. The higher dose (150 mg twice daily) gave fewer strokes or clots elsewhere in the body than warfarin with a similar rate of major bleeding. The lower dose (110 mg twice daily) gave a similar stroke rate with less major bleeding.

Also called Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group noninferiority trial with two blinded doses of dabigatran and an open-label warfarin arm (abstract; the registry gives allocation randomized, parallel model and primary purpose prevention).
Phase
Phase 3
Enrolled
  • 18,113 participants (enrolled count) (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, retrieved )
  • 18,113 patients (randomized count) (Dabigatran versus warfarin in patients with atrial fibrillation, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT00262600
Started
(actual) (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, retrieved )
Primary completion
(actual) (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, retrieved )
Completion
Not reported
Results first posted
(Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, 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, Ukraine, United Kingdom, Hong Kong SAR China, Türkiye (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

ClinicalTrials.gov NCT00262600, a phase 3, randomized, parallel-group study sponsored by Boehringer Ingelheim with the Population Health Research Institute and Uppsala University as collaborators. The main report is Connolly et al., N Engl J Med 2009;361(12):1139-51 (abstract read only). PubMed links an erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read. The registry lists a primary completion date and no completion date. The registry marks the results-first-posted date ESTIMATED, so no date type is recorded for it. No structured findings are recorded here; the numbers are on the claim.

Arms

  • Dabigatran 110 mg twice daily

    Intervention Dabigatran

    A blinded fixed dose of 110 mg twice daily (abstract). The registry labels its two dabigatran arms dose 1 and dose 2 without milligram values.

  • Dabigatran 150 mg twice daily

    Intervention Dabigatran

    A blinded fixed dose of 150 mg twice daily (abstract).

  • Warfarin

    Intervention None named

    Adjusted-dose warfarin given in an unblinded fashion (abstract). No separate entity is recorded for warfarin.

Findings

No findings are published for this study.

Record details

Record id
cardio:re-ly
Content hash
4dd6cb2755cc570c877ac493390738ec41fddb0b1493415e93a1f90cc006286b