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
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Idrabiotaparinux
Drug: Warfarin
Drug: Placebo (for idrabiotaparinux)
Drug: Placebo (for warfarin)
Drug: Avidin
Drug: Placebo (for avidin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3773
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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: 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
Active Comparator: Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
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 avidin)

Vial containing 105 mg of matching lyophilized powder for dissolution

Intravenous infusion for 30 minutes


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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580216

  Show 538 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00580216     History of Changes
Other Study ID Numbers: EFC10295, 2007-004817-33
Study First Received: December 21, 2007
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration
Russia: Pharmacological Committee, Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Sanofi:
stroke
systemic thromboembolic events

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014