A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF STUDY)

Publication date: Available online 21 February 2015 Source:American Heart Journal Author(s): Gregory Y.H. Lip , Jose Merino , Michael Ezekowitz , Kenneth Ellenbogen , Dmitry Zamoryakhin , Hans Lanz , James Jin , Naab Al-Saadi , Michele Mercuri , Andreas Goette We designed a prospective, randomized, open-label, blinded endpoint evaluation(PROBE) parallel group Phase 3b clinical trial comparing edoxaban (a new oral factor Xa inhibitor) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of non-valvular AF. The primary efficacy endpoint is the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality, from randomization until the end of follow-up (Day 56 post cardioversion). The primary safety endpoint is the composite of major and clinically-relevant non-major (CRNM) bleeding, from the first administration of study drug to end of treatment (Day 28 post cardioversion)+3 days. The primary efficacy analysis will be conducted on the intention-to-treat population whereas the primary safety analysis – on the safety population (refer to definitions in the main text). The study includes stratification on the following levels: (i) approach to cardioversion (transoesophagel echocardiography (TEE) or non-TEE) as determined by the Investigator; (ii) subject’s experience in taking anticoagulants at the time of randomization (anticoagulant-experienced or a...
Source: American Heart Journal - Category: Cardiology Source Type: research