Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Cardiology, P.C.
- Oracle Research, a Division of: The Heart Center, P.C.
- Arizona Heart Institute Mesa
- Saguaro Clinical Research
- Southern Arizona Veterans Affairs Health Care System
- Office of Dr. Bowden, D.O.
- Jerry L. Pettis VA Medical Center
- Kenneth W. Carr, M.D. Cardiology
- Richard A. Levy, M.D.
- Cardiology Specialists of Orange County
- Aurora Denver Cardiology Associates
- Denver Health and Hospital Authority Adult Medicine Clinic
- Denver Health and Hospital Authority Eastside Health Clinic
- Denver Health Medical Center
- Florida Arrhythmia Consultants
- North Broward Hospital District Cardiovascular Research Institute
- Jacksonville Cardiovascular Clinic
- Jacksonville Center for Clinical Research
- Cardiovascular Center of Sarasota
- Wellington Green Family Practice
- Beacon Medical Research
- Heart & Vascular Clinic/Advanced Medical Research
- The Clinic (Lake Charles Medical & Surgical Clinic)
- IMG Healthcare, LLC
- Baystate Medical Center
- New Mexico Heart Institute, PA
- University of New Mexico Hospital
- Practice of James A. Underberg @ Murray Hill Medical Group
- Duke University Medical Center
- The Oregon Health and Science University
- Blackstone Cardiology Associates, P.C.
- Austin Heart, P.A.
- Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
- South Texas Cardiovascular Consultants
- LDS Hospital
- Physicians Office Building (POB)
- McGuire VA Medical Center
- Swedish Medical Center
- Inland Cardiology
- Marshfield Clinic
- St. Joseph's Hospital
- Concord Repartiation General Hospital
- Cardiology Consultant's Group
- Foothills Medical Centre
- Heart Health Institute
- University of Calgary
- Dr. M.P.J. Senaratne Professional Corporation
- West Coast Cardiology Research
- Cardiac Arrhythmia Trials
- Health Care Corporation of St. John's Health Sciences Centre
- Zoom International Inc.
- Moose Jaw Cardiac Centre
- Royal University Hospital
- Saskatoon Medical Specialists
- Specialists Internal Medicine
- Dr. Joesph J. Javier
- Yorkton Regional Health Centre
- A.O. "Instituti Ospitalieri di Cremona"
- Azienda Ospedaliera San Paolo
- Azienda Ospedaliera di Parma
- U.O. di Medicina Interna II
- Centro Emostasi e Trombosi
- Academisch Ziekenhuis Maastricht
- University Hospital of Wales
- University of Glasgow
- Freeman Hospital
- New Cross Hospital