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
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 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.
Inclusion Criteria:
Main exclusion Criteria:
Beach, Florida 32168, United States
Fort Meade, South Dakota 57741, United States
Capital Federal, C1094AAD, Argentina
Woden, 2606, Australia
Envigado-Antioquia, Colombia
Ostrava Vitkovice, 70300, Czechia
Plzen - Bory, 30599, Czechia
Sittard-Geleen, 6162 BG, Netherlands
Lørenskog, 1478, Norway
Gdynia-Redlowo, 81-402, Poland
Nizniy Novgorod, 603005, Russia
Novosibirsk-117, 630117, Russia
Tainan Hsien, 710, Taiwan
Muang, 50200, Thailand