Phase 4
N=114
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT02584660 ↗Enrolled (actual)
114
Serious AEs
10.7%
Results posted
Apr 2018
Primary outcome: Primary: Mean Duration of Hospitalization — 0.191; 1.393 Days — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rivaroxaban (Drug); Standard-of-care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Scientific Affairs, LLC
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Hospitalization |
0.191; 1.393 | <.0001 sig |
| SECONDARY Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding |
0; 0; 2; 0; 3.9; 1.6 | — |
| SECONDARY Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason |
0.679; 1.513; 0.764; 1.812 | — |
| SECONDARY Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) |
51.1; 61.8; 40; 21.8; 6.7; 10.9 | — |
| SECONDARY Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire |
60.4; 62.7; 33.3; 23.7; 4.2; 6.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02584660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.