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 - BOREALIS-AF

• Conditions: The subjects who will participate to this clinical trial are not healthy volonteers.They have Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented, with an indication for long-term VKA therapy.

• Registration Number: EUCTR2007-004817-33-PT
• Lead Sponsor: sanofi-aventis recherche&développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9600

Inclusion Criteria

1. Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented.

2. With an indication for 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:
- hypertension requiring drug treatment;
- moderately or severely impaired left ventricular function and/or congestive heart
failure;
- age > 75 years;
- diabetes mellitus.

3. Written informed consent obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Criteria related to study methodology:
1. Legal lower age limitations (country specific) .
2. Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism.
3. Stroke within previous 5 days or transient ischemic attack within previous 5 days.
4. Transient AF caused by a reversible disorder.
5. Planned major surgery or cardioversion within 30 days.
6. Participation in another pharmacotherapeutic study within the prior 30 days.
7. Life expectancy < 6 months.

- Criteria related to warfarin:
8. INR > 3 at baseline.
9. Active bleeding or high risk of bleeding.
10. Hemorrhagic disorder.
11. Major surgery or trauma within previous 30 days.
12. History of intracranial, intraocular, spinal, overt gastrointestinal, retroperitoneal or a traumatic intrarticular bleeding or life-threatening bleeding.
13. Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
14. Any other contraindication listed in the labeling of warfarin.

- Criteria related to SSR126157E (biotinylated idraparinux):
15. Pregnancy or childbearing potential without proper contraceptive measures.
16. Breast feeding.
17. Hypersensitivity to SSR126517E.
18. Previous exposure to idraparinux.
19. Baseline creatinine clearance < 30 mL/min.

- Exclusion criteria related to avidin (SSR29261):
20. Known allergy to eggs or to avidin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objective is to evaluate whether once weekly subcutaneous (s.c.) injection of biotinylated idraparinux is at least as effective as oral International Normalized Ratio (INR) adjusted-dose warfarin in the prevention of stroke or systemic embolic event in patients with atrial fibrillation (AF).;Secondary Objective: The main secondary study objective is to compare the incidence of the composite endpoint (stroke or non-CNS SE or major bleeding or death) observed in the biotinylated idraparinux group with the one observed in the warfarin group.;Primary end point(s): The primary efficacy endpoint is the composite outcome of all strokes (ischemic, hemorrhagic, or undefined) and non central nervous system (CNS) systemic embolic events (SE) confirmed by the CIAC, within the planned treatment period.