Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT00070655
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4673
-
ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors:
- previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
- hypertension requiring drug treatment
- left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
- age >75 years
- age between 65-75 years plus diabetes mellitus, or
- age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
-
Written informed consent
- Legal lower age limitations (country specific)
- Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
- Transient AF caused by a reversible disorder
- Active bleeding or high risk of bleeding
- Recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
- Participation in another pharmacotherapeutic study within the prior 30 days
- Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg
- Pregnancy or childbearing potential without proper contraceptive measures
- Breastfeeding
- Any other contraindication listed in the labeling of warfarin or acenocoumarol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of all strokes and non-CNS systemic embolism.
- Secondary Outcome Measures
Name Time Method Separate components of the primary study outcome.
Trial Locations
- Locations (67)
Saskatoon Medical Specialists
🇨🇦Saskatoon, Saskatchewan, Canada
Health Care Corporation of St. John's Health Sciences Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Yorkton Regional Health Centre
🇨🇦Yorkton, Saskatchewan, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Moose Jaw Cardiac Centre
🇨🇦Moose Jaw, Saskatchewan, Canada
Dr. Joesph J. Javier
🇨🇦Yorkton, Saskatchewan, Canada
North Broward Hospital District Cardiovascular Research Institute
🇺🇸Fort Lauderdale, Florida, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
St. Joseph's Hospital
🇺🇸Marshfield, Wisconsin, United States
Denver Health and Hospital Authority Eastside Health Clinic
🇺🇸Denver, Colorado, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Richard A. Levy, M.D.
🇺🇸San Francisco, California, United States
Denver Health and Hospital Authority Adult Medicine Clinic
🇺🇸Denver, Colorado, United States
Beacon Medical Research
🇺🇸Indianapolis, Indiana, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Physicians Office Building (POB)
🇺🇸Salt Lake City, Utah, United States
Kenneth W. Carr, M.D. Cardiology
🇺🇸Oceanside, California, United States
IMG Healthcare, LLC
🇺🇸New Orleans, Louisiana, United States
Cardiology Specialists of Orange County
🇺🇸Santa Ana, California, United States
Southern Arizona Veterans Affairs Health Care System
🇺🇸Tucson, Arizona, United States
Saguaro Clinical Research
🇺🇸Tucson, Arizona, United States
Oracle Research, a Division of: The Heart Center, P.C.
🇺🇸Huntsville, Alabama, United States
Arizona Heart Institute Mesa
🇺🇸Mesa, Arizona, United States
Jerry L. Pettis VA Medical Center
🇺🇸Loma Linda, California, United States
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Office of Dr. Bowden, D.O.
🇺🇸Healdsburg, California, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Wellington Green Family Practice
🇺🇸Wellington, Florida, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States
Blackstone Cardiology Associates, P.C.
🇺🇸Pawtucket, Rhode Island, United States
Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
🇺🇸Dallas, Texas, United States
Heart & Vascular Clinic/Advanced Medical Research
🇺🇸Covington, Louisiana, United States
Austin Heart, P.A.
🇺🇸Austin, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Cardiac Arrhythmia Trials
🇨🇦Victoria, British Columbia, Canada
Inland Cardiology
🇺🇸Spokane, Washington, United States
A.O. "Instituti Ospitalieri di Cremona"
🇮🇹Cremona, Italy
Zoom International Inc.
🇨🇦St. Jerome, Quebec, Canada
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Azienda Ospedaliera San Paolo
🇮🇹Milano, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
U.O. di Medicina Interna II
🇮🇹Parma, Italy
Centro Emostasi e Trombosi
🇮🇹Rimini, Italy
Freeman Hospital
🇬🇧Newscastle Upon Tyne, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
University of Glasgow
🇬🇧Glasgow, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
The Clinic (Lake Charles Medical & Surgical Clinic)
🇺🇸Lake Charles, Louisiana, United States
Practice of James A. Underberg @ Murray Hill Medical Group
🇺🇸New York, New York, United States
Concord Repartiation General Hospital
🇦🇺Concord, Australia
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Cardiology Consultant's Group
🇨🇦Calgary, Alberta, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
West Coast Cardiology Research
🇨🇦New Westminster, British Columbia, Canada
Specialists Internal Medicine
🇨🇦Saskatoon, Saskatchewan, Canada
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Dr. M.P.J. Senaratne Professional Corporation
🇨🇦Edmonton, Alberta, Canada
Florida Arrhythmia Consultants
🇺🇸Fort Lauderdale, Florida, United States
Jacksonville Cardiovascular Clinic
🇺🇸Jacksonville, Florida, United States
Heart Health Institute
🇨🇦Calgary, Alberta, Canada