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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: SR34006 (idraparinux sodium) Injection; Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00070655

EFC5134

SR34006

Details and patient eligibility

About

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.

Enrollment: 4,673 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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