BOREALIS-AF

Evaluation of weekly subcutaneous biotinylated idrabiotaparinux versus oral adjusted-dose warfarin to prevent stroke and systemic thromboembolic events in patients with atrial fibrillation (2011)

Condition

Prevention of stroke and systemic thromboembolic events in patients with AF 

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Objective

To compare the efficacy and safety of idrabiotaparinux with adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with AF

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Trial design

Randomized, double-blind, assessor-blind, non-inferiority phase III trial
Active treatment: idrabiotaparinux 3 mg s.c. weekly for 7 weeks followed by 2 mg weekly or 1.5 mg for risk categories
Control treatment: warfarin (INR 2.0–3.0)

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Endpoints

Primary efficacy endpoint: composite of all strokes or non-CNS systemic embolic events
Secondary endpoints: separate components of the primary study outcome; composite of stroke, non-CNS systemic embolic events, major bleeding, and death

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Trial participants

Approximately 9600 patients with non-valvular AF indicating for long-term vitamin-K antagonist therapy based on the presence of previous ischemic stroke, transient ischemic attack or systemic embolism and/or at least two additional risk factors

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Results

The trial was stopped early due to sponsor’s decision not driven by any safety concern. There are no results available

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Reference

ClinicalTrials.gov (NCT00580216)

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