Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation "BOREALIS-AF"


Phase 3 Results N/A

Summary of Purpose

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF). Trial Stopped: early discontinuation based on strategic sponsor decision not driven by any safety concern

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 19 February 2016.

1 Dec 2007 21 Dec 2007 1 Oct 2010 1 Oct 2010 1 Feb 2016 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment


Not available