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

• Status: Completed
• Trial end date: 2018-05-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Bayer
• Treatments: Rivaroxaban

Criteria

Key Inclusion 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 Exclusion Criteria:

• 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