Clinical trial NCT02584660: A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Official title: MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Embolism
Keywords: Rivaroxaban
JNJ39039039
Pulmonary embolism
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2015-10-22
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Duration of Hospitalization
timeFrame: Up to Day 30
Secondary outcomes:
measure: Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
timeFrame: Up to 7, 14, 30, and 90 Days
measure: Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding
timeFrame: Up to 7, 14, 30 and 90 Days
measure: Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
timeFrame: Up to 30 and 90 Days
measure: Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
timeFrame: Day 90
measure: Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
timeFrame: Day 7
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sylmar
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Davenport
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Atlantic City
country: United States
state: New Jersey
city: Camden
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Everett
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: