MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 114
- Primary Endpoint
- Mean Duration of Hospitalization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Rivaroxaban (Drug)
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.
Intervention: Standard-of-care (Drug)
Outcomes
Primary Outcomes
Mean Duration of Hospitalization
Time Frame: Up to Day 30
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.
Secondary Outcomes
- 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)
- 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)
- 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)