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

ID#: NCT02111564

Age: 40 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: June 02, 2014

End Date: May 25, 2018

Contact Information:
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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.
Eligibility: 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