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Atrial FibrillationPhase 3NCT00070655

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

A Phase 3 study testing SR34006 (idraparinux sodium) Injection and vitamin K antagonist (warfarin or acenocoumarol) tablets in people with Atrial Fibrillation, run by Sanofi at 84 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
SR34006 (idraparinux sodium) Injection and vitamin K antagonist (warfarin or acenocoumarol) tablets
How many people
4,673 participants
Where
84 sitesin 10 countries
Study dates
Sep 2003to Mar 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

84 sites in 10 countries.

84 sites in 10 countries

United States41 sites

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico

  • University of New Mexico Hospital

    Albuquerque, New Mexico

  • Aurora Denver Cardiology Associates

    Aurora, Colorado

  • Austin Heart, P.A.

    Austin, Texas

  • Cardiology, P.C.

    Birmingham, Alabama

  • Heart & Vascular Clinic/Advanced Medical Research

    Covington, Louisiana

  • Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates

    Dallas, Texas

  • Denver Health and Hospital Authority Adult Medicine Clinic

    Denver, Colorado

  • Denver Health and Hospital Authority Eastside Health Clinic

    Denver, Colorado

  • Denver Health Medical Center

    Denver, Colorado

  • Duke University Medical Center

    Durham, North Carolina

  • Florida Arrhythmia Consultants

    Fort Lauderdale, Florida

  • North Broward Hospital District Cardiovascular Research Institute

    Fort Lauderdale, Florida

  • Office of Dr. Bowden, D.O.

    Healdsburg, California

  • Oracle Research, a Division of: The Heart Center, P.C.

    Huntsville, Alabama

  • Beacon Medical Research

    Indianapolis, Indiana

  • Jacksonville Cardiovascular Clinic

    Jacksonville, Florida

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida

  • The Clinic (Lake Charles Medical & Surgical Clinic)

    Lake Charles, Louisiana

  • Jerry L. Pettis VA Medical Center

    Loma Linda, California

  • Marshfield Clinic

    Marshfield, Wisconsin

  • St. Joseph's Hospital

    Marshfield, Wisconsin

  • Arizona Heart Institute Mesa

    Mesa, Arizona

  • IMG Healthcare, LLC

    New Orleans, Louisiana

  • Practice of James A. Underberg @ Murray Hill Medical Group

    New York, New York

  • Kenneth W. Carr, M.D. Cardiology

    Oceanside, California

  • Blackstone Cardiology Associates, P.C.

    Pawtucket, Rhode Island

  • The Oregon Health and Science University

    Portland, Oregon

  • McGuire VA Medical Center

    Richmond, Virginia

  • LDS Hospital

    Salt Lake City, Utah

  • Physicians Office Building (POB)

    Salt Lake City, Utah

  • South Texas Cardiovascular Consultants

    San Antonio, Texas

  • Richard A. Levy, M.D.

    San Francisco, California

  • Cardiology Specialists of Orange County

    Santa Ana, California

  • Cardiovascular Center of Sarasota

    Sarasota, Florida

  • Swedish Medical Center

    Seattle, Washington

  • Inland Cardiology

    Spokane, Washington

  • Baystate Medical Center

    Springfield, Massachusetts

  • Saguaro Clinical Research

    Tucson, Arizona

  • Southern Arizona Veterans Affairs Health Care System

    Tucson, Arizona

  • Wellington Green Family Practice

    Wellington, Florida

Other trials in United States

Canada15 sites

  • Cardiology Consultant's Group

    Calgary, Alberta

  • Foothills Medical Centre

    Calgary, Alberta

  • Heart Health Institute

    Calgary, Alberta

  • University of Calgary

    Calgary, Alberta

  • Dr. M.P.J. Senaratne Professional Corporation

    Edmonton, Alberta

  • Moose Jaw Cardiac Centre

    Moose Jaw, Saskatchewan

  • West Coast Cardiology Research

    New Westminster, British Columbia

  • Zoom International Inc.

    Saint-Jérôme, Quebec

  • Royal University Hospital

    Saskatoon, Saskatchewan

  • Saskatoon Medical Specialists

    Saskatoon, Saskatchewan

  • Specialists Internal Medicine

    Saskatoon, Saskatchewan

  • Health Care Corporation of St. John's Health Sciences Centre

    St. John's, Newfoundland and Labrador

  • Cardiac Arrhythmia Trials

    Victoria, British Columbia

  • Dr. Joesph J. Javier

    Yorkton, Saskatchewan

  • Yorkton Regional Health Centre

    Yorkton, Saskatchewan

Other trials in Canada

Italy8 sites

  • A.O. "Instituti Ospitalieri di Cremona"

    Cremona

  • Study site

    Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia

  • Azienda Ospedaliera San Paolo

    Milan

  • Azienda Ospedaliera di Parma

    Parma

  • U.O. di Medicina Interna II

    Parma

  • Centro Emostasi e Trombosi

    Rimini

  • Study site

    Torino, Treviso

  • Study site

    Varese

Other trials in Italy

United Kingdom5 sites

  • University Hospital of Wales

    Cardiff

  • Study site

    Exeter, Dundee, Glasgow, Merseyside, Wirral

  • University of Glasgow

    Glasgow

  • Freeman Hospital

    Newscastle Upon Tyne

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

Netherlands4 sites

  • Study site

    Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht

  • Study site

    Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk

  • Study site

    Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel

  • Academisch Ziekenhuis Maastricht

    Maastricht

Other trials in Netherlands

Australia3 sites

  • Study site

    Bondi Junction, Cairns, Camperdown, Miranda, Perth

  • Concord Repartiation General Hospital

    Concord

  • Study site

    South Australia, Tasmania, Victoria

Other trials in Australia

Denmark3 sites

  • Study site

    Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup

  • Study site

    Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn

  • Study site

    Kolding, Nykobing Mors, Odense, Skive, Svendborg

Other trials in Denmark

France3 sites

  • Study site

    Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse

  • Study site

    Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis

  • Study site

    Saint-Etienne, Toulouse

Other trials in France

New Zealand1 site

  • Study site

    Auckland, Christchurch, Hastings

Other trials in New Zealand

Poland1 site

  • Study site

    Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw

Other trials in Poland

About this 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

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.

Being tested
SR34006 (idraparinux sodium) Injection, vitamin K antagonist (warfarin or acenocoumarol) tablets
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR34006 (idraparinux sodium) InjectionDrug

  • vitamin K antagonist (warfarin or acenocoumarol) tabletsDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of all strokes and non-CNS systemic embolism.

Secondary outcomes (1)

  1. Separate components of the primary study outcome.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
4,673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070655
Sponsor's protocol ID
EFC5134
Other IDs
SR34006
Status last verified
Apr 2011
First submitted
6 Oct 2003
Last updated
6 Apr 2011
Results posted
No

Publications

  • 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.

    PubMed 34320504

  • Prins 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.

    PubMed 19348685

  • Amadeus 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.

    PubMed 18294998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SR34006 (idraparinux sodium) Injection and vitamin K antagonist (warfarin or acenocoumarol) tablets in people with Atrial Fibrillation, run by Sanofi at 84 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Canada, Italy, United Kingdom, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all strokes and non-CNS systemic embolism.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070655, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.

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