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-SK

Lead Sponsor: sanofi-aventis recherche&développement

Brief Summary: Not available

Detailed Description: Not available

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.