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.
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
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
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Capital Federal, Argentina
Corrientes, Argentina
Mar del Plata, Argentina
Morón, Argentina
Salta, Argentina
Zárate, Argentina