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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00070655 |
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 | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: SR34006 (idraparinux sodium) Injection Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5134/64720, SR34006 |
Study First Received: | October 6, 2003 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00070655 |
Health Authority: | United States: Food and Drug Administration |
Antiplasmin Heart Diseases Acenocoumarol Vitamin K |
Warfarin Atrial Fibrillation Arrhythmias, Cardiac |
Anticoagulants Molecular Mechanisms of Pharmacological Action Coagulants Growth Substances Physiological Effects of Drugs Hematologic Agents Pharmacologic Actions Hemostatics |
Fibrin Modulating Agents Pathologic Processes Antifibrinolytic Agents Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients |