Overview

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