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)
Summary We are currently running a study looking at a new drug which is an alternative to warfarin. We are looking for volunteers who have a history of Atrial Fibrillation (irregular heartbeat) and are taking warfarin. The new drug would reduce the need for regular blood tests, but we need to see if it is more or less effective in preventing heart attacks and strokes.
The ENGAGE-AF study is designed to compare a new oral anticoagulant (blood thinner) drug with warfarin (the standard therapy) in preventing strokes and heart attacks, in people with Atrial Fibrillation (AF). This is a world-wide study and will last approximately 2 years. During this time, the participants return for weekly visits for the first month and monthly thereafter.
Not everybody will be taking the new drug; some will continue taking warfarin plus placebo (dummy), others will take the new drug and placebo. Neither the participant nor those conducting the trial will know whether the participant will take the new drug or the warfarin.
Time period & commitment: Key inclusion criteria
Male or female subjects with age 21 years or over.
History of atrial fibrillation.
Key exclusion criteria
The exclusion criteria are dependent on a potential participant’s current health and medications. The Research Doctor/Nurse will review your medications to establish you are suitable for this study.