Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation (BOREALIS-AF)
|ClinicalTrials.gov Identifier: NCT00580216|
Recruitment Status : Terminated (early discontinuation based on strategic sponsor decision not driven by any safety concern)
First Posted : December 24, 2007
Last Update Posted : March 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Idrabiotaparinux sodium Drug: Warfarin Drug: Placebo (for idrabiotaparinux) Drug: Placebo (for warfarin) Drug: Avidin Drug: Placebo (for avidin)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3773 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||December 2007|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.
Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
Drug: Idrabiotaparinux sodium
Pre-filled syringes containing:
Other Names:Drug: Placebo (for warfarin)
Warfarin matching capsules
Vial containing 105 mg of lyophilized powder for dilution
Intravenous infusion for 30 minutes
Other Name: SSR29261
Active Comparator: Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Drug: Placebo (for idrabiotaparinux)
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
Drug: Placebo (for avidin)
Matching pre-filled syringes containing:
Vial containing 105 mg of matching lyophilized powder for dissolution
Intravenous infusion for 30 minutes
- Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ]
- Components of the primary study outcome measure: [ Time Frame: 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 [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580216
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|Study Director:||Clinical Sciences & Operations||Sanofi|