search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SR34006 (idraparinux sodium) Injection
vitamin K antagonist (warfarin or acenocoumarol) tablets
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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

Sites / Locations

  • Cardiology, P.C.
  • Oracle Research, a Division of: The Heart Center, P.C.
  • Arizona Heart Institute Mesa
  • Saguaro Clinical Research
  • Southern Arizona Veterans Affairs Health Care System
  • Office of Dr. Bowden, D.O.
  • Jerry L. Pettis VA Medical Center
  • Kenneth W. Carr, M.D. Cardiology
  • Richard A. Levy, M.D.
  • Cardiology Specialists of Orange County
  • Aurora Denver Cardiology Associates
  • Denver Health and Hospital Authority Adult Medicine Clinic
  • Denver Health and Hospital Authority Eastside Health Clinic
  • Denver Health Medical Center
  • Florida Arrhythmia Consultants
  • North Broward Hospital District Cardiovascular Research Institute
  • Jacksonville Cardiovascular Clinic
  • Jacksonville Center for Clinical Research
  • Cardiovascular Center of Sarasota
  • Wellington Green Family Practice
  • Beacon Medical Research
  • Heart & Vascular Clinic/Advanced Medical Research
  • The Clinic (Lake Charles Medical & Surgical Clinic)
  • IMG Healthcare, LLC
  • Baystate Medical Center
  • New Mexico Heart Institute, PA
  • University of New Mexico Hospital
  • Practice of James A. Underberg @ Murray Hill Medical Group
  • Duke University Medical Center
  • The Oregon Health and Science University
  • Blackstone Cardiology Associates, P.C.
  • Austin Heart, P.A.
  • Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
  • South Texas Cardiovascular Consultants
  • LDS Hospital
  • Physicians Office Building (POB)
  • McGuire VA Medical Center
  • Swedish Medical Center
  • Inland Cardiology
  • Marshfield Clinic
  • St. Joseph's Hospital
  • Concord Repartiation General Hospital
  • Cardiology Consultant's Group
  • Foothills Medical Centre
  • Heart Health Institute
  • University of Calgary
  • Dr. M.P.J. Senaratne Professional Corporation
  • West Coast Cardiology Research
  • Cardiac Arrhythmia Trials
  • Health Care Corporation of St. John's Health Sciences Centre
  • Zoom International Inc.
  • Moose Jaw Cardiac Centre
  • Royal University Hospital
  • Saskatoon Medical Specialists
  • Specialists Internal Medicine
  • Dr. Joesph J. Javier
  • Yorkton Regional Health Centre
  • A.O. "Instituti Ospitalieri di Cremona"
  • Azienda Ospedaliera San Paolo
  • Azienda Ospedaliera di Parma
  • U.O. di Medicina Interna II
  • Centro Emostasi e Trombosi
  • Academisch Ziekenhuis Maastricht
  • University Hospital of Wales
  • University of Glasgow
  • Freeman Hospital
  • New Cross Hospital

Outcomes

Primary Outcome Measures

Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures

Separate components of the primary study outcome.

Full Information

First Posted
October 6, 2003
Last Updated
April 5, 2011
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00070655
Brief Title
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4673 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR34006 (idraparinux sodium) Injection
Intervention Type
Drug
Intervention Name(s)
vitamin K antagonist (warfarin or acenocoumarol) tablets
Primary Outcome Measure Information:
Title
Composite of all strokes and non-CNS systemic embolism.
Secondary Outcome Measure Information:
Title
Separate components of the primary study outcome.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology, P.C.
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Oracle Research, a Division of: The Heart Center, P.C.
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Arizona Heart Institute Mesa
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Saguaro Clinical Research
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Southern Arizona Veterans Affairs Health Care System
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Office of Dr. Bowden, D.O.
City
Healdsburg
State/Province
California
Country
United States
Facility Name
Jerry L. Pettis VA Medical Center
City
Loma Linda
State/Province
California
Country
United States
Facility Name
Kenneth W. Carr, M.D. Cardiology
City
Oceanside
State/Province
California
Country
United States
Facility Name
Richard A. Levy, M.D.
City
San Francisco
State/Province
California
Country
United States
Facility Name
Cardiology Specialists of Orange County
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Denver Health and Hospital Authority Adult Medicine Clinic
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Denver Health and Hospital Authority Eastside Health Clinic
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Florida Arrhythmia Consultants
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
North Broward Hospital District Cardiovascular Research Institute
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Jacksonville Cardiovascular Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Wellington Green Family Practice
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Beacon Medical Research
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Heart & Vascular Clinic/Advanced Medical Research
City
Covington
State/Province
Louisiana
Country
United States
Facility Name
The Clinic (Lake Charles Medical & Surgical Clinic)
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
IMG Healthcare, LLC
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
New Mexico Heart Institute, PA
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Practice of James A. Underberg @ Murray Hill Medical Group
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
The Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Blackstone Cardiology Associates, P.C.
City
Pawtucket
State/Province
Rhode Island
Country
United States
Facility Name
Austin Heart, P.A.
City
Austin
State/Province
Texas
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates
City
Dallas
State/Province
Texas
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Physicians Office Building (POB)
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Inland Cardiology
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
Country
United States
Facility Name
St. Joseph's Hospital
City
Marshfield
State/Province
Wisconsin
Country
United States
City
Bondi Junction, Cairns, Camperdown, Miranda, Perth
Country
Australia
Facility Name
Concord Repartiation General Hospital
City
Concord
Country
Australia
City
South Australia, Tasmania, Victoria
Country
Australia
Facility Name
Cardiology Consultant's Group
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Heart Health Institute
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Dr. M.P.J. Senaratne Professional Corporation
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
West Coast Cardiology Research
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Health Care Corporation of St. John's Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Zoom International Inc.
City
St. Jerome
State/Province
Quebec
Country
Canada
Facility Name
Moose Jaw Cardiac Centre
City
Moose Jaw
State/Province
Saskatchewan
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Saskatoon Medical Specialists
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Specialists Internal Medicine
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Dr. Joesph J. Javier
City
Yorkton
State/Province
Saskatchewan
Country
Canada
Facility Name
Yorkton Regional Health Centre
City
Yorkton
State/Province
Saskatchewan
Country
Canada
City
Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup
Country
Denmark
City
Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn
Country
Denmark
City
Kolding, Nykobing Mors, Odense, Skive, Svendborg
Country
Denmark
City
Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse
Country
France
City
Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis
Country
France
City
Saint-Etienne, Toulouse
Country
France
Facility Name
A.O. "Instituti Ospitalieri di Cremona"
City
Cremona
Country
Italy
City
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera di Parma
City
Parma
Country
Italy
Facility Name
U.O. di Medicina Interna II
City
Parma
Country
Italy
Facility Name
Centro Emostasi e Trombosi
City
Rimini
Country
Italy
City
Torino, Treviso
Country
Italy
City
Varese
Country
Italy
City
Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht
Country
Netherlands
City
Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk
Country
Netherlands
City
Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
City
Auckland, Christchurch, Hastings
Country
New Zealand
City
Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw
Country
Poland
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
City
Exeter, Dundee, Glasgow, Merseyside, Wirral
Country
United Kingdom
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newscastle Upon Tyne
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34320504
Citation
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.
Results Reference
derived
PubMed Identifier
19348685
Citation
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.
Results Reference
derived
PubMed Identifier
18294998
Citation
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. Erratum In: Lancet. 2008 Dec 13;372(9655):2022.. Thorp-Pedersen, C [corrected to Torp-Pedersen, C].
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs