Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.
Key Inclusion Criteria:
Key Exclusion Criteria:
Ciudad de Buenos Aires, Argentina
East Saint Kilda, Australia
Vychulki, Brest Region, Brest, Belarus
Jablonec Na Nisou, Czechia
Hilleroed, Denmark
Karlsbad, Germany
Achaïa, Greece
Kifisia, Athens, Greece
Thessalonikis, Greece
Berettyóújfalú, Hungary
Farkasgyepü, Hungary
Gyõr, Hungary
Krāslavas Apriņķis, Latvia
Vilniaus Apskritis, Lithuania
Sittard-Geleen, Netherlands
Sopot,Gdynia, Poland
Tarn W N/a, Poland
Tg Mures, Romania
Vsevolzhsk, Russia
Durban Kwa Zulu Natal, South Africa
Gatesville Cape Town, South Africa
Groenkloof, Pretoria, South Africa
Majadahonda-Madrid, Spain
Torrelavega Cantabria, Spain
Ivano-Frankivsky, Ukraine
Angus, United Kingdom