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

Official Title: “A Multicenter, 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 Systemic Thromboembolic Events in Patients With Atrial Fibrillation”

The objective of this study is to evaluate wether the new investigational, neutralizable blood thinner (anticoagulant) "biotinylated idraparinux", administered once weekly under the skin, is at least as efficient to prevent clots in brain and in the other organs than the standard of care with warfarin an oral anticoagulant whose doses are adjusted according to a regular monitoring of a blood coagulation test (INR) in patients with heart rhythm disorder called "atrial fibrillation".

Intervention(s) in this Clinical Trial

• Drug: SSR126517E "biotinylated idraparinux"
  • once-weekly subcutaneous injection
• Drug: warfarin
  • oral INR adjusted-dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• composite of all strokes or non central nervous system (CNS) systemic embolic events (SE)
  • Time Frame: end of study
    Safety Issue?: No

Secondary Measures

• separate components of the primary study outcome
  • Time Frame: end of study
    Safety Issue?: No
• composite (stroke or non CNS SE or major bleeding or death)
  • Time Frame: end of study
    Safety Issue?: No

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 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 Transient Ischemic Attack within previous 5 days
• Transient atrial fibrillation 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
• Pregnant or childbearing potential without proper contraceptive measures or breast feeding.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Clinical Sciences & Operations Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580216

Study ID Number: EFC10295

ClinicalTrials.gov Identifier: NCT00580216

Health Authority: United States: Food and Drug Administration