NCT02111564

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,024 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure
• Respiratory Insufficiency
• Stroke Acute
• Infectious Diseases
• Rheumatic Diseases

Interventions

Type	Name	Description
DRUG	Rivaroxaban, 10 mg	Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (\>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.
DRUG	Rivaroxaban, 7.5 mg	Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from \>=30 to less than (\<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
DRUG	Placebo	All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Timeline

• Start date: 2014-01-07
• Primary completion: 2018-03-06
• Completion: 2018-05-03
• First posted: 2014-04-11
• Last updated: 2019-11-25
• Results posted: 2019-11-25

Locations

594 sites across 37 countries: United States, Argentina, Australia, Austria, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, Georgia, Germany, Greece, Hungary, Israel, Latvia, Lithuania, Mexico, Netherlands, North Macedonia, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom