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

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: SR34006 (idraparinux sodium) Injection
* Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets


Participation Criteria
=================
Eligibility 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: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SR34006 (idraparinux sodium) Injection|nan|
|Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all strokes and non-CNS systemic embolism. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Separate components of the primary study outcome. |  |  |