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

NCT02584660 | Completed Phase 4 Results DMC

• 2 other identifiers: CR10769439039039APE4001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 50

Brief 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.

Conditions

Pulmonary Embolism

Keywords

Rivaroxaban; JNJ39039039; Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Hospitalization

  Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.

  Up to Day 30

Secondary Outcomes (5)

• Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death

  Up to 7, 14, 30, and 90 Days

• Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding

  Up to 7, 14, 30 and 90 Days

• Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason

  Up to 30 and 90 Days

• Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)

  Day 90

• Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire

  Day 7

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

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.

Drug: Rivaroxaban

local Standard-of-care

EXPERIMENTAL

Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.

Drug: Standard-of-care

Interventions

Rivaroxaban DRUG

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.

Rivaroxaban

Standard-of-care DRUG

Standard-of-care as per local protocol and defined by the medical team caring for the participant.

local Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead
• Bayer: collaborator

Study Sites (50)

Unknown Facility

Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Sylmar, California, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Davenport, Iowa, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Jackson, Michigan, United States

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Lansing, Michigan, United States

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Royal Oak, Michigan, United States

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St Louis, Missouri, United States

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Atlantic City, New Jersey, United States

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Camden, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Zanesville, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Bellingham, Washington, United States

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Everett, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rivaroxaban; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen Scientific Affairs, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: October 22, 2015
• Study Start: October 15, 2015
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: June 1, 2018
• Results First Posted: April 20, 2018

Record last verified: 2018-05

Locations

US (50)