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

April 5, 2011 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4673

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bondi Junction, Cairns, Camperdown, Miranda, Perth, Australia
      • Concord, Australia
        • Concord Repartiation General Hospital
      • South Australia, Tasmania, Victoria, Australia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre
      • Calgary, Alberta, Canada
        • University of Calgary
      • Calgary, Alberta, Canada
        • Cardiology Consultant's Group
      • Calgary, Alberta, Canada
        • Heart Health Institute
      • Edmonton, Alberta, Canada
        • Dr. M.P.J. Senaratne Professional Corporation
    • British Columbia
      • New Westminster, British Columbia, Canada
        • West Coast Cardiology Research
      • Victoria, British Columbia, Canada
        • Cardiac Arrhythmia Trials
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Health Care Corporation of St. John's Health Sciences Centre
    • Quebec
      • St. Jerome, Quebec, Canada
        • Zoom International Inc.
    • Saskatchewan
      • Moose Jaw, Saskatchewan, Canada
        • Moose Jaw Cardiac Centre
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
      • Saskatoon, Saskatchewan, Canada
        • Saskatoon Medical Specialists
      • Saskatoon, Saskatchewan, Canada
        • Specialists Internal Medicine
      • Yorkton, Saskatchewan, Canada
        • Dr. Joesph J. Javier
      • Yorkton, Saskatchewan, Canada
        • Yorkton Regional Health Centre
  • 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
      • Cremona, Italy
        • A.O. "Instituti Ospitalieri di Cremona"
      • Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia, Italy
      • Milano, Italy
        • Azienda Ospedaliera San Paolo
      • Parma, Italy
        • Azienda Ospedaliera Di Parma
      • Parma, Italy
        • U.O. di Medicina Interna II
      • Rimini, Italy
        • Centro Emostasi e Trombosi
      • 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
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
  • New Zealand
      • Auckland, Christchurch, Hastings, New Zealand
  • Poland
      • Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw, Poland
  • United Kingdom
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Exeter, Dundee, Glasgow, Merseyside, Wirral, United Kingdom
      • Glasgow, United Kingdom
        • University of Glasgow
      • Newscastle Upon Tyne, United Kingdom
        • Freeman Hospital
      • Wolverhampton, United Kingdom
        • New Cross Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Cardiology, P.C.
      • Huntsville, Alabama, United States
        • Oracle Research, a Division of: The Heart Center, P.C.
    • Arizona
      • Mesa, Arizona, United States
        • Arizona Heart Institute Mesa
      • Tucson, Arizona, United States
        • Saguaro Clinical Research
      • Tucson, Arizona, United States
        • Southern Arizona Veterans Affairs Health Care System
    • California
      • Healdsburg, California, United States
        • Office of Dr. Bowden, D.O.
      • Loma Linda, California, United States
        • Jerry L. Pettis VA Medical Center
      • Oceanside, California, United States
        • Kenneth W. Carr, M.D. Cardiology
      • San Francisco, California, United States
        • Richard A. Levy, M.D.
      • Santa Ana, California, United States
        • Cardiology Specialists of Orange County
    • Colorado
      • Aurora, Colorado, United States
        • Aurora Denver Cardiology Associates
      • Denver, Colorado, United States
        • 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
    • Florida
      • Fort Lauderdale, Florida, United States
        • Florida Arrhythmia Consultants
      • Fort Lauderdale, Florida, United States
        • North Broward Hospital District Cardiovascular Research Institute
      • Jacksonville, Florida, United States
        • Jacksonville Cardiovascular Clinic
      • Jacksonville, Florida, United States
        • Jacksonville Center for Clinical Research
      • Sarasota, Florida, United States
        • Cardiovascular Center of Sarasota
      • Wellington, Florida, United States
        • Wellington Green Family Practice
    • Indiana
      • Indianapolis, Indiana, United States
        • Beacon Medical Research
    • Louisiana
      • Covington, Louisiana, United States
        • Heart & Vascular Clinic/Advanced Medical Research
      • Lake Charles, Louisiana, United States
        • The Clinic (Lake Charles Medical & Surgical Clinic)
      • New Orleans, Louisiana, United States
        • IMG Healthcare, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Baystate Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States
        • University of New Mexico Hospital
      • Albuquerque, New Mexico, United States
        • New Mexico Heart Institute, PA
    • New York
      • New York, New York, United States
        • Practice of James A. Underberg @ Murray Hill Medical Group
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States
        • The Oregon Health and Science University
    • Rhode Island
      • Pawtucket, Rhode Island, United States
        • Blackstone Cardiology Associates, P.C.
    • Texas
      • Austin, Texas, United States
        • Austin Heart, P.A.
      • Dallas, Texas, United States
        • Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
      • San Antonio, Texas, United States
        • South Texas Cardiovascular Consultants
    • Utah
      • Salt Lake City, Utah, United States
        • LDS Hospital
      • Salt Lake City, Utah, United States
        • Physicians Office Building (POB)
    • Virginia
      • Richmond, Virginia, United States
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States
        • Swedish Medical Center
      • Spokane, Washington, United States
        • Inland Cardiology
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States
        • St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures

Outcome Measure
Separate components of the primary study outcome.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 6, 2003

First Submitted That Met QC Criteria

October 8, 2003

First Posted (Estimate)

October 9, 2003

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5134
  • SR34006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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