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Completed

NCT Number: NCT00070655

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bondi Junction, Cairns, Camperdown, Miranda, Perth, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SR34006 (idraparinux sodium) Injection

Drug

vitamin K antagonist (warfarin or acenocoumarol) tablets

Drug

Primary outcomes

  1. Composite of all strokes and non-CNS systemic embolism.

Secondary outcomes

  1. Separate components of the primary study outcome.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 9, 2003
Registry last updated
Apr 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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