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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2008/091/000018
• Date of registration: 13-02-2008
• Prospective Registration: Yes
• Primary sponsor: SanofiSynthelabo India Limited
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 13-02-2008
• Target sample size: 9600
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

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

• Name: Salini James
• Affiliation: Sanofi Synthelabo India Limited

• Name: Salini James
• Affiliation: Sanofi Synthelabo India Limited

Key inclusion & exclusion 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: 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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

separate components of the primary study outcomeTimepoint: end of study

Secondary ID(s)

NCT00580216

EFC10295

Source(s) of Monetary Support

Sanofi-Synthelabo (India) Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093

Ethics review

Status: Approved
Approval date:
Contact:

Safe Search Independent Ethics Committee, Ahmedabad