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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00070655

Enrollment

4673

Registered

2003-10-09

Start date

2003-09-30

Completion date

2006-03-31

Last updated

2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DRUGSR34006 (idraparinux sodium) Injection

DRUGvitamin K antagonist (warfarin or acenocoumarol) tablets

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite of all strokes and non-CNS systemic embolism.	—

Secondary

Measure	Time frame
Separate components of the primary study outcome.	—

Countries

Australia, Canada, Denmark, France, Italy, Netherlands, New Zealand, Poland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026