A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.
Inclusion Criteria:
Exclusion Criteria:
Wolloongabba, Australia
Feldkirch Vorarlberg Vorarlber, Austria
Tulln Niederosterreich Niedero, Austria
Wien Wien, Austria
Rio de Janeiro Br, Brazil
Russel, Bulgaria
E. London, Ontario, Canada
North York, Ontario, Canada
Arica I Region, Chile
Chila, Chile
Concepción VIII, Chile
Osorno X Region, Chile
Osorno X Región, Chile
Rancagua VI Region, Chile
San Felipe V Region, Chile
Santiago de Chile Rm, Chile
Santiago Rm, Chile
Temuco IX, Chile
Valdivia X Región, Chile
Viña Del Mar V Región, Chile
Barranquilla Atlántico Atlanti, Colombia
Bogota D C, Colombia
Bogota Dc, Colombia
Bogotá Dc Dc, Colombia
Bogotá Dc, Colombia
Cali Valle Del Cauca, Colombia
Cali Valley Del Cauca, Colombia
Medellin Antioquia, Colombia
Praha 10 N/A, Czechia
Uherské Hradistì 6, Czechia
Koege, Denmark
Béziers Languedoc-Roussillon, France
Berlin/Spandau, Germany
Henstedt-Rhen, Germany
Homburg/Saar, Germany
Karlsbad, Germany
Athens Attica, Greece
Maroussi Athens, Greece
Piraeus Attica, Greece
Voula Attica, Greece
Kln, Hong Kong
Budapest Nap, Hungary
Debrecen County, Hungary
Gyõr, Hungary
Kesckemet, Hungary
Gandhinagar Guiarat, India
Hyderabad Andra Pradesh, India
Kelantan, Malaysia
Sarawak, Malaysia
Culiacán Sinaloa/Mèxico, Mexico
Monterrey Nuevo Leòn, Mexico
Gc Tilburg, Netherlands
Takapuna Auckland, New Zealand
L41 Lima Lima, Peru
Lima 1 Lima Lima, Peru
Cebuu City, Philippines
Katowice-Ochojec, Poland
Starogard Gdanski Nap, Poland
Szczecin Nap, Poland
Tg Mures, Romania
Chelyabinsk Chelyabinsk Region, Russia
Novosibirsk Nap, Russia
Tyumen Tyumen Region, Russia
Yaroslavl Nap, Russia
Bloemfontein Free State, South Africa
Bloemfontein Orange Free State, South Africa
Cape Town Western Cape, South Africa
Centurion Gauteng, South Africa
Durban Kwa Zulu Natal, South Africa
Johannesburg Gauteng, South Africa
Kempton Park Gauteng, South Africa
Port Elizabeth Eastern Cape, South Africa
Pretoria Gauteng, South Africa
Somerset West Western Cape, South Africa
Worcester Western Cape, South Africa
Kyonggi-Do, South Korea
Sungnam, South Korea
Baracaldo Vizcaya, Spain
San Sebastián Guipúzcoa, Spain
Basel Bs, Switzerland
Tamshui, Taiwan
Phathumwan, Thailand
Ratchatewi, Thailand
Malatya Nap, Turkey (Türkiye)
O1103 Kyiv, Ukraine
Simferopil, Ukraine
Vinnitsya, Ukraine
Cambridgeshire, United Kingdom
Devon, United Kingdom
Maracaibo Estado Zulia, Venezuela
Maracay Estado Aragua, Venezuela