Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00070655

Run by

Sanofi

People needed

4673

Starts

2003-09-01

Expected to finish

2006-03-01

Last updated by the study team

2011-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• Denver Health and Hospital Authority Adult Medicine Clinic — Denver, Colorado, United States
• Denver Health and Hospital Authority Eastside Health Clinic — Denver, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Florida Arrhythmia Consultants — Fort Lauderdale, Florida, United States
• North Broward Hospital District Cardiovascular Research Institute — Fort Lauderdale, Florida, United States
• Jacksonville Cardiovascular Clinic — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Cardiovascular Center of Sarasota — Sarasota, Florida, United States
• Wellington Green Family Practice — Wellington, Florida, United States
• Beacon Medical Research — Indianapolis, Indiana, United States
• Heart & Vascular Clinic/Advanced Medical Research — Covington, Louisiana, United States
• The Clinic (Lake Charles Medical & Surgical Clinic) — Lake Charles, Louisiana, United States
• IMG Healthcare, LLC — New Orleans, Louisiana, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Cardiology, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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