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.
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Anticoagulant (Vitamin K antagonist)
- SR34006 (idraparinux sodium) Injection Drug
- Vitamin K antagonist (warfarin or acenocoumarol) tablets Drug
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
Patient must have ECG-documented atrial fibrillation and need long-term vitamin K antagonist therapy.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Find a replacement for vitamin K antagonists (especially warfarin) with agents that are comparably effective but less likely to cause bleeding and easier to use and manage.|
|Primary||Composite of all strokes and non-CNS systemic embolism.|
|Secondary||Separate components of the primary study outcome.|
- Sanofi-Aventis Lead