We're sorry, but this trial is no longer enrolling volunteers.
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.
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
- Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer > 2* upper limit of normal (ULN), or 2 with D-dimer > 2*ULN Key
- Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
- Serious trauma (including head trauma) within 4 weeks before randomization
- History of hemorrhagic stroke at any time in the past
- Any medical condition that requires chronic use of any parenteral or oral anticoagulation
Please contact Melissa Minor to learn more about where you can participate in this trial. Please use the contact form on the right side.