| December 21, 2007 |
| October 19, 2009 |
| December 2007 |
| March 2011 (final data collection date for primary outcome measure) |
| composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ] [ Designated as safety issue: No ] |
| composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ] |
| Complete list of historical versions of study NCT00580216 on ClinicalTrials.gov Archive Site |
- separate components of the primary study outcome [ Time Frame: end of study ] [ Designated as safety issue: No ]
- composite (stroke or non CNS SE or major bleeding or death) [ Time Frame: end of study ] [ Designated as safety issue: No ]
|
- separate components of the primary study outcome [ Time Frame: end of study ]
- composite (stroke or non CNS SE or major bleeding or death) [ Time Frame: end of study ]
|
| |
| Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation |
| 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". |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Atrial Fibrillation |
- Drug: SSR126517E "biotinylated idraparinux"
- Drug: warfarin
|
| |
| |
| |
| Recruiting |
| 9600 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, India, Indonesia, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, Venezuela |
| |
| NCT00580216 |
| ICD Study Director, sanofi-aventis |
| EFC10295, EudraCT 2007-004817-33 |
| Sanofi-Aventis |
|
| Study Director: |
ICD |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| October 2009 |
