Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
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|ClinicalTrials.gov Identifier: NCT00070655|
Recruitment Status : Completed
First Posted : October 9, 2003
Last Update Posted : April 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: SR34006 (idraparinux sodium) Injection Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4673 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- Composite of all strokes and non-CNS systemic embolism.
- Separate components of the primary study outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070655
|Study Director:||ICD CSD||Sanofi|