Official Title: “The AMADEUS Trial, A Multicenter, Randomized, Open-Label, Assessor Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous Idraparinux (SR34006) With Adjusted-Dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

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

Primary Measures

• Composite of all strokes and non-CNS systemic embolism.

Secondary Measures

• Separate components of the primary study outcome.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00070655

Study ID Number: EFC5134/64720

ClinicalTrials.gov Identifier: NCT00070655

Health Authority: United States: Food and Drug Administration