# RE-LY

Study · id `cardio:re-ly` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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

Browse, organ or system: Heart  
Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

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.

## 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. 2009;361(12):1139-51 (abstract read only; the journal is on the cited PubMed record). PubMed links an erratum (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.

## Key facts

- 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: 18113 participants (enrolled count; Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14); 18113 patients (randomized count; Dabigatran versus warfarin in patients with atrial fibrillation, snapshot `cardio:pubmed-19717844-2026-10-14`, retrieved 2026-10-14)
- Started: 2005-12 (actual) (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2009-04 (actual) (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14)
- Completion: Not reported
- Results first posted: 2011-02-10 (Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate, snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14)
- 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, snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct00262600-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests two doses of dabigatran against warfarin: Dabigatran (`cardio:dabigatran`)
- Lists atrial fibrillation as its first condition: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`)
- Lead sponsor on the registry record: Boehringer Ingelheim (`cardio:boehringer-ingelheim`)

## Provenance

Content hash: 4120292cd7308a4ca0cac2fc2bc66a2f25a33f424c8be11b1416902365deec61
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14