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

 1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism

 2. hypertension requiring drug treatment

 3. left ventricular dysfunction (left ventricular ejection fraction <45% or
 symptomatic congestive heart failure)

 4. age >75 years

 5. age between 65-75 years plus diabetes mellitus, or

 6. 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