Trial Information

Summary: A multi-center, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with oral adjusted-dose warfarin in the prevention of stroke and systematic thromboembolic events in patients with atrial fibrillation.

The primary objective of this study is to evaluate whether once-weekly subcutaneous injection of biotinylated idraparinux is at least effective as warfarin in the prevention of stroke or systemic thromboembolic event in patients with atrial fibrillation.

Patient Inclusion Criteria:

1. permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented
2. written informed consent
3. indication for long-term VKA therapy based on the presence of previous ischemic stroke, TIA or systemic embolism; and/or at least two of the following risk factors:
4. 1. hypertension requiring drug treatment
   2. moderately or severly impaired left ventricular function and/or congestive heart failure
   3. age > 75years
   4. diabetes mellitus

Patient Exclusion Criteria:

1. indication for VKA other than atrial fibrillation, including prosthetic heart valves, venous thromboembolism
2. stroke within previous 5 days or transient ischemic attack within previous 5 days
3. transient atrial fib caused by a reversible disorder
4. planned major surgery or cardioversion within 30 days

If you would like to learn more about participating in this study, please send an e-mail message using the form below.