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


Phase 3 Results

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:
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