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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00580216

Acronym

BOREALIS-AF

Enrollment

3773

Registered

2007-12-24

Start date

2007-12-31

Completion date

2010-10-31

Last updated

2016-03-21

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

Conditions

Atrial Fibrillation

Keywords

stroke, systemic thromboembolic events

Brief summary

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).

Detailed description

The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized. All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months. All participants will have then an 6-month observational period after cessation of study treatment.

Interventions

DRUGIdrabiotaparinux sodium

Pre-filled syringes containing: * 0.5 mL for the 3.0 mg dosage; * 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); * 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection

DRUGWarfarin

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration

DRUGPlacebo (for idrabiotaparinux)

Matching pre-filled syringes containing: * 0.5 mL for the 3.0 mg dosage; * 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); * 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection

DRUGPlacebo (for warfarin)

Warfarin matching capsules Oral administration

DRUGAvidin

Vial containing 105 mg of lyophilized powder for dilution Intravenous infusion for 30 minutes

DRUGPlacebo (for avidin)

Vial containing 105 mg of matching lyophilized powder for dissolution Intravenous infusion for 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Non valvular atrial fibrillation (AF) * Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (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 \> or = 75 years, diabetes mellitus. Main

Exclusion criteria

* Indication for VKA other than AF * Stroke or TIA within previous 5 days * Transient AF caused by a reversible disorder * Planned major surgery/trauma or cardioversion within 30 days * INR \> 3 at baseline * Active bleeding or high risk of bleeding * Uncontrolled hypertension * Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.

Design outcomes

Primary

Measure	Time frame
Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)	From randomization up to the end of the treatment period (minimum of 6 months)

Secondary

Measure	Time frame
Components of the primary study outcome measure:	From randomization up to the end of the treatment period (minimum of 6 months)
Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death	From randomization up to the end of the treatment period (minimum of 6 months)

Countries

Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czechia, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, India, Indonesia, Israel, Italy, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026