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

Phase 3

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT00070655
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-10-06
• Study First Submitted QC: 2003-10-08
• Study First Posted: 2003-10-09
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-05
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4673

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures

Name	Time	Method
Separate components of the primary study outcome.

Trial Locations

Locations (67)

Cardiology, P.C.; 🇺🇸 Birmingham, Alabama, United States

Oracle Research, a Division of: The Heart Center, P.C.; 🇺🇸 Huntsville, Alabama, United States

Arizona Heart Institute Mesa; 🇺🇸 Mesa, Arizona, United States

Saguaro Clinical Research; 🇺🇸 Tucson, Arizona, United States

Southern Arizona Veterans Affairs Health Care System; 🇺🇸 Tucson, Arizona, United States

Office of Dr. Bowden, D.O.; 🇺🇸 Healdsburg, California, United States

Jerry L. Pettis VA Medical Center; 🇺🇸 Loma Linda, California, United States

Kenneth W. Carr, M.D. Cardiology; 🇺🇸 Oceanside, California, United States

Richard A. Levy, M.D.; 🇺🇸 San Francisco, California, United States

Cardiology Specialists of Orange County; 🇺🇸 Santa Ana, California, United States

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