A clinical trial to study the safety and efficacy of a new drug biotinylated idraparinux (SSR126517E) as compared to another drug warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillatio
- Conditions
- -I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48
- Registration Number
- PER-067-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is documented by an ECG.
• With an indication of 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: 1) hypertension that requires treatment with medication; 2) Left ventricular function with moderate or severe damage and / or congestive heart failure; 3) age> 75 years; 4) diabetes mellitus.
• Informed consent obtained.
• Legal limitations for minority (specific to each country).
• Indication of VKA other than AF, including prosthetic heart valves, venous thromboembolism.
• EVC 5 days before or transient ischemic attack within the previous 5 days.
• Passive AF caused by a reversible disorder.
• Major planned surgery or cardioversion within 30 days.
• Participation in another pharmacotherapeutic study within the previous 30 days.
• Life expectancy <6 months.
• INR> 3 in the baseline.
• Active hemorrhage or high risk of bleeding.
• Hemorrhagic disorder.
• Major surgery or trauma within the previous 30 days.
• History of intracranial, intraocular, spinal, evident gastrointestinal, retro peritoneal or intra-articular traumatic hemorrhage or life-threatening hemorrhage.
• Uncontrolled hypertension: systolic blood pressure> 180 mm Hg and / or diastolic blood pressure> 110 mm Hg
• Any other contraindication mentioned on the warfarin label (see Appendix D).
• Pregnancy or ability to procreate without appropriate contraceptive measures
• Being in breastfeeding period
• Hypersensitivity to SSR126517E
• Previous exhibition to idraparinux
• Basal creatinine clearance <30 mL / min
• Known allergy to eggs or avidin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The cerebral vascular event is defined as the presence of a new focal neurological deficit through the vascularization in origin, with signs or symptoms that last more than 24 hours if the patient survives. Cerebral vascular events will then be classified by the CIAC as ischemic, hemorrhagic or undefined<br>Measure:Set of all cerebral vascular events (ischemic, hemorrhagic or undefined) or non-CNS SE, defined by the CIAC, within the planned treatment period of the patient.<br>Timepoints:within the planned treatment period of the patient.<br>
- Secondary Outcome Measures
Name Time Method