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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00070655 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Oracle Research, a Division of: The Heart Center, P.C. | |
| Huntsville, Alabama, United States | |
| Cardiology, P.C. | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Arizona Heart Institute Mesa | |
| Mesa, Arizona, United States | |
| Saguaro Clinical Research | |
| Tucson, Arizona, United States | |
| Southern Arizona Veterans Affairs Health Care System | |
| Tucson, Arizona, United States | |
| United States, California | |
| Jerry L. Pettis VA Medical Center | |
| Loma Linda, California, United States | |
| Office of Dr. Bowden, D.O. | |
| Healdsburg, California, United States | |
| Richard A. Levy, M.D. | |
| San Francisco, California, United States | |
| Cardiology Specialists of Orange County | |
| Santa Ana, California, United States | |
| Kenneth W. Carr, M.D. Cardiology | |
| Oceanside, California, United States | |
| United States, Colorado | |
| Denver Health Medical Center | |
| Denver, Colorado, United States | |
| Denver Health and Hospital Authority Adult Medicine Clinic | |
| Denver, Colorado, United States | |
| Denver Health and Hospital Authority Eastside Health Clinic | |
| Denver, Colorado, United States | |
| Aurora Denver Cardiology Associates | |
| Aurora, Colorado, United States | |
| United States, Florida | |
| Cardiovascular Center of Sarasota | |
| Sarasota, Florida, United States | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States | |
| Jacksonville Cardiovascular Clinic | |
| Jacksonville, Florida, United States | |
| Wellington Green Family Practice | |
| Wellington, Florida, United States | |
| North Broward Hospital District Cardiovascular Research Institute | |
| Fort Lauderdale, Florida, United States | |
| Florida Arrhythmia Consultants | |
| Fort Lauderdale, Florida, United States | |
| United States, Indiana | |
| Beacon Medical Research | |
| Indianapolis, Indiana, United States | |
| United States, Louisiana | |
| IMG Healthcare, LLC | |
| New Orleans, Louisiana, United States | |
| Heart & Vascular Clinic/Advanced Medical Research | |
| Covington, Louisiana, United States | |
| The Clinic (Lake Charles Medical & Surgical Clinic) | |
| Lake Charles, Louisiana, United States | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States | |
| United States, New Mexico | |
| New Mexico Heart Institute, PA | |
| Albuquerque, New Mexico, United States | |
| University of New Mexico Hospital | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Practice of James A. Underberg @ Murray Hill Medical Group | |
| New York, New York, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| United States, Oregon | |
| The Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, Rhode Island | |
| Blackstone Cardiology Associates, P.C. | |
| Pawtucket, Rhode Island, United States | |
| United States, Texas | |
| Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates | |
| Dallas, Texas, United States | |
| South Texas Cardiovascular Consultants | |
| San Antonio, Texas, United States | |
| Austin Heart, P.A. | |
| Austin, Texas, United States | |
| United States, Utah | |
| LDS Hospital | |
| Salt Lake City, Utah, United States | |
| Physicians Office Building (POB) | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| McGuire VA Medical Center | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Inland Cardiology | |
| Spokane, Washington, United States | |
| Swedish Medical Center | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States | |
| St. Joseph's Hospital | |
| Marshfield, Wisconsin, United States | |
| Australia | |
| Bondi Junction, Cairns, Camperdown, Miranda, Perth, Australia | |
| South Australia, Tasmania, Victoria, Australia | |
| Concord Repartiation General Hospital | |
| Concord, Australia | |
| Canada, Alberta | |
| Heart Health Institute | |
| Calgary, Alberta, Canada | |
| Cardiology Consultant's Group | |
| Calgary, Alberta, Canada | |
| Dr. M.P.J. Senaratne Professional Corporation | |
| Edmonton, Alberta, Canada | |
| University of Calgary | |
| Calgary, Alberta, Canada | |
| Foothills Medical Centre | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| Cardiac Arrhythmia Trials | |
| Victoria, British Columbia, Canada | |
| West Coast Cardiology Research | |
| New Westminster, British Columbia, Canada | |
| Canada, Newfoundland and Labrador | |
| Health Care Corporation of St. John's Health Sciences Centre | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Quebec | |
| Zoom International Inc. | |
| St. Jerome, Quebec, Canada | |
| Canada, Saskatchewan | |
| Saskatoon Medical Specialists | |
| Saskatoon, Saskatchewan, Canada | |
| Specialists Internal Medicine | |
| Saskatoon, Saskatchewan, Canada | |
| Yorkton Regional Health Centre | |
| Yorkton, Saskatchewan, Canada | |
| Dr. Joesph J. Javier | |
| Yorkton, Saskatchewan, Canada | |
| Moose Jaw Cardiac Centre | |
| Moose Jaw, Saskatchewan, Canada | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada | |
| Denmark | |
| Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup, Denmark | |
| Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn, Denmark | |
| Kolding, Nykobing Mors, Odense, Skive, Svendborg, Denmark | |
| France | |
| Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse, France | |
| Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis, France | |
| Saint-Etienne, Toulouse, France | |
| Italy | |
| Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia, Italy | |
| Varese, Italy | |
| Torino, Treviso, Italy | |
| Centro Emostasi e Trombosi | |
| Rimini, Italy | |
| Azienda Ospedaliera di Parma | |
| Parma, Italy | |
| Azienda Ospedaliera San Paolo | |
| Milano, Italy | |
| A.O. "Instituti Ospitalieri di Cremona" | |
| Cremona, Italy | |
| U.O. di Medicina Interna II | |
| Parma, Italy | |
| Netherlands | |
| Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht, Netherlands | |
| Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk, Netherlands | |
| Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel, Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands | |
| New Zealand | |
| Auckland, Christchurch, Hastings, New Zealand | |
| Poland | |
| Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw, Poland | |
| United Kingdom | |
| University Hospital of Wales | |
| Cardiff, United Kingdom | |
| University of Glasgow | |
| Glasgow, United Kingdom | |
| Freeman Hospital | |
| Newscastle Upon Tyne, United Kingdom | |
| New Cross Hospital | |
| Wolverhampton, United Kingdom | |
| Exeter, Dundee, Glasgow, Merseyside, Wirral, United Kingdom | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC5134, SR34006 |
| Study First Received: | October 6, 2003 |
| Last Updated: | April 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070655 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Heart Diseases Anticoagulants Coagulants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Hematologic Agents Warfarin Hemostatics Pharmacologic Actions Fibrin Modulating Agents |
Antifibrinolytic Agents Pathologic Processes Acenocoumarol Vitamins Therapeutic Uses Vitamin K Cardiovascular Diseases Micronutrients Atrial Fibrillation Arrhythmias, Cardiac |