Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
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
2 other identifiers
interventional
4,673
10 countries
84
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Sep 2003
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 6, 2003
CompletedFirst Posted
Study publicly available on registry
October 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedApril 6, 2011
April 1, 2011
2.5 years
October 6, 2003
April 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of all strokes and non-CNS systemic embolism.
Secondary Outcomes (1)
Separate components of the primary study outcome.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
- hypertension requiring drug treatment
- left ventricular dysfunction (left ventricular ejection fraction \<45% or symptomatic congestive heart failure)
- age \>75 years
- age between 65-75 years plus diabetes mellitus, or
- age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (84)
Cardiology, P.C.
Birmingham, Alabama, United States
Oracle Research, a Division of: The Heart Center, P.C.
Huntsville, Alabama, United States
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
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
Aurora Denver Cardiology Associates
Aurora, 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
Denver Health Medical Center
Denver, Colorado, United States
Florida Arrhythmia Consultants
Fort Lauderdale, Florida, United States
North Broward Hospital District Cardiovascular Research Institute
Fort Lauderdale, Florida, United States
Jacksonville Cardiovascular Clinic
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Wellington Green Family Practice
Wellington, Florida, United States
Beacon Medical Research
Indianapolis, Indiana, United States
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
Baystate Medical Center
Springfield, Massachusetts, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Practice of James A. Underberg @ Murray Hill Medical Group
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Oregon Health and Science University
Portland, Oregon, United States
Blackstone Cardiology Associates, P.C.
Pawtucket, Rhode Island, United States
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
LDS Hospital
Salt Lake City, Utah, United States
Physicians Office Building (POB)
Salt Lake City, Utah, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Inland Cardiology
Spokane, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
St. Joseph's Hospital
Marshfield, Wisconsin, United States
Unknown Facility
Bondi Junction, Cairns, Camperdown, Miranda, Perth, Australia
Concord Repartiation General Hospital
Concord, Australia
Unknown Facility
South Australia, Tasmania, Victoria, Australia
Cardiology Consultant's Group
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
Heart Health Institute
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
Dr. M.P.J. Senaratne Professional Corporation
Edmonton, Alberta, Canada
West Coast Cardiology Research
New Westminster, British Columbia, Canada
Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
Health Care Corporation of St. John's Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
Zoom International Inc.
Saint-JĂ©rĂ´me, Quebec, Canada
Moose Jaw Cardiac Centre
Moose Jaw, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, Canada
Specialists Internal Medicine
Saskatoon, Saskatchewan, Canada
Dr. Joesph J. Javier
Yorkton, Saskatchewan, Canada
Yorkton Regional Health Centre
Yorkton, Saskatchewan, Canada
Unknown Facility
Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup, Denmark
Unknown Facility
Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn, Denmark
Unknown Facility
Kolding, Nykobing Mors, Odense, Skive, Svendborg, Denmark
Unknown Facility
Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse, France
Unknown Facility
Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis, France
Unknown Facility
Saint-Etienne, Toulouse, France
A.O. "Instituti Ospitalieri di Cremona"
Cremona, Italy
Unknown Facility
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia, Italy
Azienda Ospedaliera San Paolo
Milan, Italy
Azienda Ospedaliera di Parma
Parma, Italy
U.O. di Medicina Interna II
Parma, Italy
Centro Emostasi e Trombosi
Rimini, Italy
Unknown Facility
Torino, Treviso, Italy
Unknown Facility
Varese, Italy
Unknown Facility
Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht, Netherlands
Unknown Facility
Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk, Netherlands
Unknown Facility
Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Unknown Facility
Auckland, Christchurch, Hastings, New Zealand
Unknown Facility
Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw, Poland
University Hospital of Wales
Cardiff, United Kingdom
Unknown Facility
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
Related Publications (3)
Ding WY, Lip GYH, Shantsila A. Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial. Cerebrovasc Dis. 2022;51(1):29-35. doi: 10.1159/000517608. Epub 2021 Jul 28.
PMID: 34320504DERIVEDPrins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
PMID: 19348685DERIVEDAmadeus Investigators; Bousser MG, Bouthier J, Buller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Torp-Pedersen C, Wyse DG. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet. 2008 Jan 26;371(9609):315-21. doi: 10.1016/S0140-6736(08)60168-3.
PMID: 18294998DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2003
First Posted
October 9, 2003
Study Start
September 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
April 6, 2011
Record last verified: 2011-04