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.
Drug: SR34006 (idraparinux sodium) Injection
Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|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|
- Composite of all strokes and non-CNS systemic embolism.
- Separate components of the primary study outcome.
|Study Start Date:||September 2003|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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|Study Director:||ICD CSD||Sanofi|