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Clinical Trials/CTRI/2008/091/000018
CTRI/2008/091/000018OtherPhase 3

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

SanofiSynthelabo India Limited0 sites9,600 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Other
Sponsor
Enrollment
9,600
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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.

Investigators

Sponsor
SanofiSynthelabo India Limited

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