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

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Warfarin

Drug: Placebo (for idrabiotaparinux)

Drug: Avidin

Drug: Placebo (for avidin)

Drug: Idrabiotaparinux sodium

Drug: Placebo (for warfarin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00580216

2007-004817-33 (EudraCT Number)

EFC10295

Details and patient eligibility

About

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

Full 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 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.

Enrollment

3,773 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

3,773 participants in 2 patient groups

Idrabiotaparinux

Experimental group

Description:

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).

Treatment: