NCT02584660

A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.

Detailed description

This is a randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, multicenter (study conducted at multiple sites) study to evaluate that low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments. Safety will be monitored during the study.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.
DRUG	Standard-of-care	Standard-of-care as per local protocol and defined by the medical team caring for the participant.

Timeline

• Start date: 2015-10-15
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2015-10-22
• Last updated: 2018-06-01
• Results posted: 2018-04-20

Locations

50 sites across 1 country: United States