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

Completed · Phase 4

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT02584660

Run by

Janssen Scientific Affairs, LLC

People needed

114

Starts

2015-10-15

Expected to finish

2017-03-22

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
• A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low risk of clinical deterioration as determined by the Hestia criteria
• Have no contraindications to and be able to complete randomized treatment and all study assessments
• Have a life expectancy of at least 6 months
• Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

You may not qualify if…

• Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450) inhibitors (such as but not limited to ketoconazole, telithromycin or protease inhibitors) use within 4 days before randomization, or planned use during the study. Itraconazole use within 7 days before randomization or planned use during the study
• Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned use during the study
• Who Has contraindications to the use of any anticoagulant therapy (example, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy documented at Screening)
• Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
• Woman who is pregnant, or breast-feeding, or planning to become pregnant

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Sylmar, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Davenport, Iowa, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Jackson, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Atlantic City, New Jersey, United States
• Study site — Camden, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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