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-AT

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 (i) 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.

(i) The diagnosis of valvular AF” includes one of the following:
• Rheumatic mitral valve disease,
• Prosthetic heart valves (already taken into account in exclusion criterion #2) or previous heart valve surgery (including valve repair)
• Patients with active infective endocarditis.
A patient with any of these abnormalities does not fulfil the inclusion criteria of non-valvular AF” and therefore cannot be randomized.
Conversely, all patients with valvular abnormalities not listed above, can be randomized.
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 biotinylated idraparinux.
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.