A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)

MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Rivaroxaban; Drug: 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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States
  • Arizona
    • Chandler, Arizona, United States
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • California
    • Los Angeles, California, United States
    • Sacramento, California, United States
    • Sylmar, California, United States
  • Connecticut
    • New Haven, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Pensacola, Florida, United States
    • Tampa, Florida, United States
  • Iowa
    • Davenport, Iowa, United States
    • Iowa City, Iowa, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Springfield, Massachusetts, United States
  • Michigan
    • Detroit, Michigan, United States
    • Jackson, Michigan, United States
    • Lansing, Michigan, United States
    • Royal Oak, Michigan, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New Jersey
    • Atlantic City, New Jersey, United States
    • Camden, New Jersey, United States
  • New York
    • Brooklyn, New York, United States
    • Buffalo, New York, United States
    • New York, New York, United States
    • Stony Brook, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Charlotte, North Carolina, United States
    • Durham, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Toledo, Ohio, United States
    • Zanesville, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States
    • Bethlehem, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
    • West Reading, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
  • Texas
    • Dallas, Texas, United States
    • Fort Worth, Texas, United States
    • Houston, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
  • Washington
    • Bellingham, Washington, United States
    • Everett, Washington, United States
    • Spokane, Washington, United States
    • Tacoma, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Rivaroxaban; 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.
Experimental: 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.	Drug: Standard-of-care; Standard-of-care as per local protocol and defined by the medical team caring for the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death	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.	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	Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.	Up to 7, 14, 30 and 90 Days
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason	Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.	Up to 30 and 90 Days
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)	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.	Day 90
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire	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.	Day 7

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): March 22, 2017
• Study Completion (Actual): March 22, 2017

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Rivaroxaban; Pulmonary embolism; JNJ39039039
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: CR107694; 39039039APE4001 (Other Identifier: Janssen Scientific Affairs, LLC)