Clinical trial NCT00070655: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-10-09
Enrollment: 4673
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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:

  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

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