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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,773
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
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
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
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)
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Warfarin matching capsules Oral administration
Vial containing 105 mg of lyophilized powder for dilution Intravenous infusion for 30 minutes
Vial containing 105 mg of matching lyophilized powder for dissolution Intravenous infusion for 30 minutes
Sanofi-Aventis Investigational Site Number 840227
Mobile, Alabama, United States
Sanofi-Aventis Investigational Site Number 840209
Tucson, Arizona, United States
Sanofi-Aventis Investigational Site Number 840255
Little Rock, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840224
Little Rock, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840179
Mountain Home, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840270
Beverly Hills, California, United States
Sanofi-Aventis Investigational Site Number 840278
Beverly Hills, California, United States
Sanofi-Aventis Investigational Site Number 840241
Burbank, California, United States
Sanofi-Aventis Investigational Site Number 840010
Corona, California, United States
Sanofi-Aventis Investigational Site Number 840195
Encino, California, United States
...and 528 more locations