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Success Stops Drug Trial: Apixaban Prevents Stroke in Patients With Atrial Fibrillation Who Are Unsuitable for Warfarin
Thursday, September 2, 2010
By: Science Daily
Science Daily
The data monitoring committee of the AVERROES study, seeing
overwhelming evidence of the success of apixaban in the prevention of stroke in
patients with atrial fibrillation who are unsuitable for the conventional
treatment of warfarin, has recommended early termination of this study. The
decision came after repeated review and careful consideration of all efficacy
and safety data.
The study leaders, principal investigator Dr. Stuart J.
Connolly, chairman of the steering committee Dr. Salim Yusuf, and project
officer Dr. John Eikelboom, have accepted this recommendation, as have the
study sponsors, Bristol-Myers Squibb and Pfizer.
Results of the study were presented by Connolly at the
annual European Society of Cardiology Congress in Stockholm, Sweden, on August
31.
The AVERROES study enrolled 5,600 patients with atrial
fibrillation at risk for stroke who were unsuitable for therapy with a Vitamin
K antagonist such as warfarin. These patients were randomized, double-blind, to
receive either apixaban or the standard therapy which is Aspirin. The primary
efficacy outcome of the AVERROES study was a composite of stroke or systemic
embolism and the major safety outcome was major bleeding.
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