DU-176b Versus Warfarin In Subjects with Atrial Fibrillation
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation – Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF TIMI - 48)
IRAS ID
10193
Sponsor organisation
Daiichi Sankyo Inc
Eudract number
2008-004522-16
Clinicaltrials.gov Identifier
Research summary
Atrial fibrillation (AF) is the most common type of arrhythmia (abnormal heart rhythm) in adults and is associated with an increased risk of stroke (blood clot in the brain) and thromboembolic complications (in general terms a blockage in a blood vessel that interrupts the blood flow). Vitamin K antagonists (VKAs), such as warfarin, are anticoagulants commonly used to treat this condition. However there are inherent risks associated with its use, such as known drug and food interactions which impair its effectiveness and the need for regular blood monitoring to manage safe and effective dose administration. Due to these clinical limitations alternative oral anticoagulant therapies, which may be easier to manage, are being investigated in clinical studies.This Phase 3 study is designed to evaluate the safety and efficacy of DU-176b, compared with warfarin, in subjects with AF. If demonstrated to be safe and effective, DU-176b could represent a potential alternative to VKAs in the reduction of the risk of stroke and thromboembolic complications in patients with AF. Subjects with history of AF who also fulfilledall the study inclusion requirements have been randomised to one of three treatment groups: DU-176b high dose regimen, DU-176b low dose regimen or warfarin. This is a blinded study, so neither the subject nor the study doctor know which treatment subjects are receiving. The study will continue until a number of clinical events set in advance has been registered. It is anticipated that the study will last approximately three years, with median treatment duration being two years. An independent data monitoring committee monitors the safety and well being of subjects during the study on a regular basis. This study is being funded by Daiichi Sankyo Pharma Development and has already finished recruitment with 21,107 patients enrolled from sites located in North and South America, Africa, Asia, Europe, Australia and New Zealand.
REC name
London - Riverside Research Ethics Committee
REC reference
09/H0706/8
Date of REC Opinion
13 Feb 2009
REC opinion
Further Information Favourable Opinion