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.

All labels observed (3)

How this entity was disambiguated

Statements (47)

Predicate Object
instanceOf clinical trial ⓘ
phase III trial ⓘ
randomized controlled trial ⓘ
acronym RE-LY ⓘ
linked to: RE-LY trial
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 ⓘ
linked to: RE-LY trial
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 ⓘ
linked to: dabigatran
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 ⓘ
therapeuticArea cardiology ⓘ
thrombosis and hemostasis ⓘ
warfarinTargetINR 2.0–3.0 ⓘ

How these facts were elicited

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

dabigatran → hasClinicalTrial → RE-LY trial ⓘ
RE-LY trial → fullName → Randomized Evaluation of Long-Term Anticoagulation Therapy ⓘ
linked to: RE-LY trial
RE-LY trial → acronym → RE-LY ⓘ
linked to: RE-LY trial