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RELY- Randomized Evaluation for Long term anticoagulation therapy
Summary
RELY was a randomized, parallel,open-label, active controlled, non-inferiority trial of two doses of dabigatran etexilate compared to warfarin in patients with non-valvular atrial fibrillation. The trial was designed to evaluate whether 150 mg bid and 110 mg bid of dabigatran etexilate are non-inferior to adjusted dose warfarin (target INR of 2.0-3.0) in the prevention of stroke and systemic embolism in AF patients with additional risk factors for stroke. Treatment of AF with oral anticoagulants substantially reduces the risk of stroke but is associated with concomitant risk of bleeding. Treatment with Vitamin K antagonists requires regular monitoring and dose adjustments during treatment which results in substantial underuse. Dabigatran etexilate which is given as a fixed dose ,twice daily will be more acceptable to patients than warfarin.
Description
Approximately 18,000 patients with a diagnosis of non-valvular AF and an additional risk factor for stroke comprised the study population from approximately 800 sites world wide. The duration of treatment for each patient was a minimum of 12 months and maximum of three years. Warfarin was the chosen active control. A balanced sample of populations who were warfarin na•ve or warfarin treated subjects was established via an IVRS system during randomization processes. Subjects were randomized to receive study warfarin once daily dosed to target INR of 2.0 to 3.0, dabigatran 110 mg twice daily or dabigatran 150 mg twice daily. Visit schedules followed according to protocol with monthly safety lab draws and 3 month clinic visits for the first year of treatment and clinic visits every three months in the second and third years. Much information has been published with regard to this trial. A rollover trial for dabigatran patients, RELY_ABLE, is ongoing.WUH is participating.
Inclusion/exclusion
Documented Atrial Fibrillation ( protocol specific definition)plus one additional risk factor for stroke defined as: History of previous stroke EF<40% within the previous 6 months symptomatic heart failure NYHA class II or greater in the previous 6 months age >75 years of age or age >65 years with additional risk factors Exclusion criteria: Numerous criteria including but not limited to: gastricduodenal ulcers, hemorrahagic disorder or bleeding diathesis, renal or hepatic impairment, disabling stroke within the previous 6 months, serious bleeding events
Principal Investigator
Joseph Germano,D.O.
Department
Division Of Cardiology
Email
jgermano@winthrop.org
Other Contact
Wendy Drewes, BSN, RN 516-663-2929 wdrewes@winthrop.org
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