CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,024 enrolled
Drug / intervention
Rivaroxaban, 10 mg +2 moredrug
Likely dose
Rivaroxaban, 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02111564
NCT02111564Phase 3Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Apr 11, 2014·Updated Nov 25, 2019

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban, 10 mg, Rivaroxaban, 7.5 mg, and 1 other intervention for Heart Failure and 4 related conditions. Completed, enrolled 12,024 participants across 594 sites in 37 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Respiratory Insufficiency, Stroke Acute, Infectious Diseases, Rheumatic Diseases
CountriesArgentina, 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, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 11, 2014
Enrollment StartJan 7, 2014
Primary CompletionMar 6, 2018
Study CompletionMay 3, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.2 years ago

Interventions

Rivaroxaban, 10 mgdrug

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.

Rivaroxaban, 7.5 mgdrug

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.

Placebodrug

All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.