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

Phase 4

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Standard-of-care; Drug: Rivaroxaban

• Registration Number: NCT02584660
• Lead Sponsor: Janssen Scientific Affairs, LLC

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 Timeline

• Study First Submitted: 2015-09-11
• Study Start: 2015-10-15
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2017-03-22
• Study Completion: 2017-03-22
• Results First Submitted: 2018-03-21
• Results First Submitted QC: 2018-03-21
• Results First Posted: 2018-04-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Duration of Hospitalization	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 Outcome Measures

Name	Time	Method
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 of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
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	Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason	Up to 30 and 90 Days	Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)	Day 90	ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire	Day 7	The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.