RE-LY trial
E861731
The RE-LY trial was a large, pivotal clinical study that compared the efficacy and safety of the oral anticoagulant dabigatran with warfarin for stroke prevention in patients with atrial fibrillation.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
clinical trial
ⓘ
phase III trial ⓘ randomized controlled trial ⓘ |
| acronym | RE-LY NERFINISHED ⓘ |
| anticoagulantMechanismStudied | direct thrombin inhibition ⓘ |
| clinicalQuestion | whether dabigatran can replace warfarin for stroke prevention in atrial fibrillation ⓘ |
| comparatorDrug | warfarin ⓘ |
| comparatorDrugClass | vitamin K antagonist ⓘ |
| controlGroup | dose-adjusted warfarin ⓘ |
| dabigatranDoseArm |
110 mg twice daily
ⓘ
150 mg twice daily ⓘ |
| designFeature |
blinded dabigatran doses
ⓘ
multicenter ⓘ open-label warfarin arm ⓘ prospective ⓘ randomized ⓘ |
| drugClassStudied | direct thrombin inhibitor ⓘ |
| efficacyOutcome |
hemorrhagic stroke
ⓘ
ischemic stroke ⓘ systemic embolism ⓘ |
| enrollmentSize | over 18,000 patients ⓘ |
| fullName | Randomized Evaluation of Long-Term Anticoagulation Therapy NERFINISHED ⓘ |
| geographicScope | international ⓘ |
| impact |
influenced atrial fibrillation stroke prevention guidelines
ⓘ
supported regulatory approval of dabigatran for stroke prevention in atrial fibrillation ⓘ |
| indicationStudied | nonvalvular atrial fibrillation ⓘ |
| interventionDrug | dabigatran etexilate NERFINISHED ⓘ |
| keyFinding |
both dabigatran doses reduced intracranial hemorrhage compared with warfarin
ⓘ
dabigatran 110 mg twice daily had lower major bleeding than warfarin ⓘ dabigatran 110 mg twice daily was noninferior to warfarin for stroke or systemic embolism ⓘ dabigatran 150 mg twice daily increased gastrointestinal bleeding compared with warfarin ⓘ dabigatran 150 mg twice daily reduced stroke or systemic embolism compared with warfarin ⓘ overall mortality was similar or slightly lower with dabigatran compared with warfarin ⓘ |
| patientCondition | increased risk of stroke ⓘ |
| patientPopulation | adult patients ⓘ |
| population | patients with atrial fibrillation at risk of stroke ⓘ |
| primaryEndpoint | stroke or systemic embolism ⓘ |
| primaryObjective | to compare dabigatran with warfarin for stroke prevention in atrial fibrillation ⓘ |
| publicationType | landmark trial in anticoagulation ⓘ |
| resultInterpretation | dabigatran is an effective alternative to warfarin for many patients with atrial fibrillation ⓘ |
| safetyEndpoint | major bleeding ⓘ |
| safetyOutcome |
gastrointestinal bleeding
ⓘ
intracranial hemorrhage ⓘ |
| sponsor | Boehringer Ingelheim NERFINISHED ⓘ |
| therapeuticArea |
cardiology
ⓘ
thrombosis and hemostasis ⓘ |
| warfarinTargetINR | 2.0–3.0 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.