Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)

Phase 3

Completed

• Conditions: venous thrombo-embolism; 10014523

• Registration Number: NL-OMON41904
• Lead Sponsor: Janssen Research & Development, L.L.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 295

Inclusion Criteria

•Must be hospitalized at least 3 consecutive days and up to 14 days for an acute medical condition such as congestive heart failure, acute respiratory insufficiency or acute exacerbation of chronic obstructive pulmonary disease, acute ischemic stroke, acute infectious diseases or inflammatory diseases, including rheumatic disease
•Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score >=3

Exclusion Criteria

•Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
•Serious trauma within 4 weeks before randomization
•History of hemorrhagic stroke at any time in the past
•Severe head trauma within 3 months of randomization
•Any medical condition that requires chronic use of any parenteral or oral anticoagulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is the composite of all symptomatic VTE events<br /><br>(lower extremity DVT, non-fatal PE) and VTE-related death.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The secondary efficacy outcomes are the following:<br /><br>- VTE-related death<br /><br>- Symptomatic VTE (DVT and non-fatal PE)<br /><br>- The composite of symptomatic VTE and ACM<br /><br>- ACM<br /><br>• Exploratory efficacy outcomes are:<br /><br>- Symptomatic DVT<br /><br>- Symptomatic PE<br /><br>- Upper extremity DVT<br /><br>- The composite of the primary efficacy outcome and CV events (fatal and<br /><br>non-fatal MI and nonhemorrhagic stroke)<br /><br>- Fatal and non-fatal MI<br /><br>- Fatal and non-fatal non-hemorrhagic stroke<br /><br>- Re-hospitalization for symptomatic VTE within 30 days after randomization</p><br>