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

Not Applicable

Completed

• Conditions: -I48 Atrial fibrillation and flutter; Atrial fibrillation and flutter; I48

• Registration Number: PER-067-08
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-02
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• 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.

Exclusion Criteria

• 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