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 fibrillation

A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation - BOREALIS AF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000018

Enrollment

9600

Registered

2008-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Atrial fibrillation Health Condition 2: I489- Unspecified atrial fibrillation and atrial flutter

Interventions

Intervention1: Biotinylated Idraparinux & Avidin: 3mg/week for initial 7 weeks and thereafter 1.5mg/week or 2mg/week depending on renal clearance.Minimum 6 months

maximum 2.5 years Control Intervention1: Warfarin: Dose adjustment will be based on INR reading

Minimum 6 months

maximum 2.5 years

Eligibility

Inclusion criteria

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 (1) hypertension requiring drug treatment; (2) moderately or severely impaired left ventricular function and/or congestive heart failure; (3) age > 75 years; (4) diabetes mellitus

Exclusion criteria

Exclusion criteria: 1. Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism. 2. Stroke within previous 5 days or transient ischemic attack within previous 5 days. 3. Transient AF caused by a reversible disorder. 4. Planned major surgery or cardioversion within 30 days. 5. INR > 3 at baseline. 6. Uncontrolled hypertension: systolic blood pressure > 180 mm Hg &/or diastolic blood pressure > 110 mm Hg. 7. Active bleeding or high risk of bleeding 8. Pregnant or childbearing potential without proper contraceptive measures or breast feeding.

Design outcomes

Primary

Measure	Time frame
composite of all strokes or non central nervous system (CNS) systemic embolic events (SE)Timepoint: End of study	—

Secondary

Measure	Time frame
separate components of the primary study outcomeTimepoint: end of study	—

Countries

Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, India, Indonesia, Israel, Italy, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Other, Panama, Peru, Poland, Portugal, Republic of Korea, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United States of America

Contacts

Public ContactSalini James

Sanofi Synthelabo India Limited

salini.james@sanofi.com912230707820

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026