Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation (BOREALIS-AF)
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|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|
|Actual Primary Completion Date :||October 2010|
|Actual 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580216
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|Study Director:||Clinical Sciences & Operations||Sanofi|