A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
NCT ID: NCT02584660
Last Updated: 2018-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
114 participants
INTERVENTIONAL
2015-10-15
2017-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rivaroxaban
Participants will receive Rivaroxaban 15 milligram (mg) orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food, for approximately 69 days for a total treatment duration of 90 days.
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.
local Standard-of-care
Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Standard-of-care
Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Interventions
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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.
Standard-of-care
Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Montgomery, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
Sylmar, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Davenport, Iowa, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Jackson, Michigan, United States
Lansing, Michigan, United States
Royal Oak, Michigan, United States
St Louis, Missouri, United States
Atlantic City, New Jersey, United States
Camden, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Bellingham, Washington, United States
Everett, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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39039039APE4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR107694
Identifier Type: -
Identifier Source: org_study_id
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