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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00070655
First received: October 6, 2003
Last updated: April 5, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: SR34006 (idraparinux sodium) Injection
Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures:
  • Separate components of the primary study outcome.

Enrollment: 4673
Study Start Date: September 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070655

  Show 84 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00070655     History of Changes
Other Study ID Numbers: EFC5134, SR34006
Study First Received: October 6, 2003
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acenocoumarol
Warfarin
Vitamin K
Vitamins
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on June 17, 2013