Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Biotin; Idrabiotaparinux; Idraparinux; SANORG 34006; Warfarin

Criteria

Inclusion Criteria:

• Non valvular atrial fibrillation (AF)

• Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.

Main exclusion Criteria:

• Indication for VKA other than AF

• Stroke or TIA within previous 5 days

• Transient AF caused by a reversible disorder

• Planned major surgery/trauma or cardioversion within 30 days

• INR > 3 at baseline

• Active bleeding or high risk of bleeding

• Uncontrolled hypertension

• Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.