This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol. The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets. Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,673
Cardiology, P.C.
Birmingham, Alabama, United States
Oracle Research, a Division of: The Heart Center, P.C.
Huntsville, Alabama, United States
Arizona Heart Institute Mesa
Mesa, Arizona, United States
Saguaro Clinical Research
Tucson, Arizona, United States
Southern Arizona Veterans Affairs Health Care System
Tucson, Arizona, United States
Composite of all strokes and non-CNS systemic embolism.
Separate components of the primary study outcome.
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Office of Dr. Bowden, D.O.
Healdsburg, California, United States
Jerry L. Pettis VA Medical Center
Loma Linda, California, United States
Kenneth W. Carr, M.D. Cardiology
Oceanside, California, United States
Richard A. Levy, M.D.
San Francisco, California, United States
Cardiology Specialists of Orange County
Santa Ana, California, United States
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