Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00070655
First received: October 6, 2003
Last updated: April 5, 2011
Last verified: April 2011
  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 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures:
  • Separate components of the primary study outcome.

Enrollment: 4673
Study Start Date: September 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
    2. hypertension requiring drug treatment
    3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
    4. age >75 years
    5. age between 65-75 years plus diabetes mellitus, or
    6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
  • Written informed consent

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
  • Transient AF caused by a reversible disorder
  • Active bleeding or high risk of bleeding
  • Recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
  • Participation in another pharmacotherapeutic study within the prior 30 days
  • Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
  • Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg
  • Pregnancy or childbearing potential without proper contraceptive measures
  • Breastfeeding
  • Any other contraindication listed in the labeling of warfarin or acenocoumarol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070655

  Hide Study Locations
Locations
United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States
Oracle Research, a Division of: The Heart Center, P.C.
Huntsville, 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
Office of Dr. Bowden, D.O.
Healdsburg, California, United States
Jerry L. Pettis VA Medical Center
Loma Linda, California, United States
Kenneth W. Carr, M.D. Cardiology
Oceanside, California, United States
Richard A. Levy, M.D.
San Francisco, California, United States
Cardiology Specialists of Orange County
Santa Ana, California, United States
United States, Colorado
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Denver Health and Hospital Authority Eastside Health Clinic
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Denver Health and Hospital Authority Adult Medicine Clinic
Denver, Colorado, United States
United States, Florida
Florida Arrhythmia Consultants
Fort Lauderdale, Florida, United States
North Broward Hospital District Cardiovascular Research Institute
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Cardiovascular Clinic
Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Wellington Green Family Practice
Wellington, Florida, United States
United States, Indiana
Beacon Medical Research
Indianapolis, Indiana, United States
United States, Louisiana
Heart & Vascular Clinic/Advanced Medical Research
Covington, Louisiana, United States
The Clinic (Lake Charles Medical & Surgical Clinic)
Lake Charles, Louisiana, United States
IMG Healthcare, LLC
New Orleans, 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
Austin Heart, P.A.
Austin, Texas, United States
Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
Dallas, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, 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
Swedish Medical Center
Seattle, Washington, United States
Inland Cardiology
Spokane, 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
Concord Repartiation General Hospital
Concord, Australia
South Australia, Tasmania, Victoria, Australia
Canada, Alberta
Heart Health Institute
Calgary, Alberta, Canada
Cardiology Consultant's Group
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
Dr. M.P.J. Senaratne Professional Corporation
Edmonton, Alberta, Canada
Canada, British Columbia
West Coast Cardiology Research
New Westminster, British Columbia, Canada
Cardiac Arrhythmia Trials
Victoria, 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
Moose Jaw Cardiac Centre
Moose Jaw, Saskatchewan, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, Canada
Specialists Internal Medicine
Saskatoon, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Dr. Joesph J. Javier
Yorkton, Saskatchewan, Canada
Yorkton Regional Health Centre
Yorkton, 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
A.O. "Instituti Ospitalieri di Cremona"
Cremona, Italy
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia, Italy
Azienda Ospedaliera San Paolo
Milano, Italy
Azienda Ospedaliera di Parma
Parma, Italy
U.O. di Medicina Interna II
Parma, Italy
Centro Emostasi e Trombosi
Rimini, Italy
Torino, Treviso, Italy
Varese, 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
Exeter, Dundee, Glasgow, Merseyside, Wirral, United Kingdom
University of Glasgow
Glasgow, United Kingdom
Freeman Hospital
Newscastle Upon Tyne, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00070655     History of Changes
Other Study ID Numbers: EFC5134, SR34006
Study First Received: October 6, 2003
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acenocoumarol
Warfarin
Vitamin K
Vitamins
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on April 17, 2014