Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation (BOREALIS-AF)

This study has been terminated.
(early discontinuation based on strategic sponsor decision not driven by any safety concern)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00580216
First received: December 21, 2007
Last updated: February 26, 2014
Last verified: February 2014

December 21, 2007
February 26, 2014
December 2007
October 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ]
Complete list of historical versions of study NCT00580216 on ClinicalTrials.gov Archive Site
  • Components of the primary study outcome measure: [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • separate components of the primary study outcome [ Time Frame: end of study ]
  • composite (stroke or non CNS SE or major bleeding or death) [ Time Frame: end of study ]
Not Provided
Not Provided
 
Evaluation of Weekly Subcutaneous Biotinylated Idraparinux 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

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux 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).

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 (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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Idrabiotaparinux

    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

    Other Names:
    • SSR126517
    • Biotinylated idraparinux
  • Drug: Warfarin

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

    Oral administration

  • Drug: Placebo (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

  • Drug: Placebo (for warfarin)

    Warfarin matching capsules

    Oral administration

  • Drug: Avidin

    Vial containing 105 mg of lyophilized powder for dilution

    Intravenous infusion for 30 minutes

    Other Name: SSR29261
  • Drug: Placebo (for avidin)

    Vial containing 105 mg of matching lyophilized powder for dissolution

    Intravenous infusion for 30 minutes

  • Experimental: Idrabiotaparinux

    Idrabiotaparinux, 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).

    Interventions:
    • Drug: Idrabiotaparinux
    • Drug: Placebo (for warfarin)
    • Drug: Avidin
  • Active Comparator: Warfarin
    Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
    Interventions:
    • Drug: Warfarin
    • Drug: Placebo (for idrabiotaparinux)
    • Drug: Placebo (for avidin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3773
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belarus,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Costa Rica,   Croatia,   Czech Republic,   Denmark,   Egypt,   Estonia,   Finland,   France,   Greece,   Guatemala,   India,   Indonesia,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Norway,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   Venezuela
 
NCT00580216
EFC10295, 2007-004817-33
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP