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

October 6, 2003
April 5, 2011
September 2003
March 2006   (final data collection date for primary outcome measure)
Composite of all strokes and non-CNS systemic embolism.
Not Provided
Complete list of historical versions of study NCT00070655 on ClinicalTrials.gov Archive Site
Separate components of the primary study outcome.
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: SR34006 (idraparinux sodium) Injection
  • Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4673
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   France,   Italy,   Netherlands,   New Zealand,   Poland,   United Kingdom
 
NCT00070655
EFC5134, SR34006
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP