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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rivaroxaban
Standard-of-care
Sponsored by
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Rivaroxaban, JNJ39039039, Pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rivaroxaban

local Standard-of-care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 11, 2015
Last Updated
May 4, 2018
Sponsor
Janssen Scientific Affairs, LLC
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02584660
Brief Title
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Acronym
MERCURY PE
Official Title
MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
March 22, 2017 (Actual)
Study Completion Date
March 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Rivaroxaban, JNJ39039039, Pulmonary embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
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.
Arm Title
local Standard-of-care
Arm Type
Experimental
Arm Description
Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard-of-care
Intervention Description
Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Primary Outcome Measure Information:
Title
Mean Duration of Hospitalization
Description
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.
Time Frame
Up to Day 30
Secondary Outcome Measure Information:
Title
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
Description
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.
Time Frame
Up to 7, 14, 30, and 90 Days
Title
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding
Description
Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
Time Frame
Up to 7, 14, 30 and 90 Days
Title
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
Description
Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
Time Frame
Up to 30 and 90 Days
Title
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
Description
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.
Time Frame
Day 90
Title
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
City
Montgomery
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Alabama
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United States
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Chandler
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Phoenix
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Tucson
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Los Angeles
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Sacramento
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Sylmar
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New Haven
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Pensacola
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Detroit
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Jackson
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Lansing
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Royal Oak
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Saint Louis
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Camden
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Buffalo
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Stony Brook
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Chapel Hill
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Charlotte
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Durham
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Winston-Salem
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Cincinnati
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Cleveland
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Toledo
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Zanesville
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Portland
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Allentown
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Bethlehem
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Philadelphia
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Pittsburgh
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West Reading
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Charleston
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South Carolina
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Dallas
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Fort Worth
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Houston
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Salt Lake City
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Charlottesville
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Virginia
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Bellingham
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Everett
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Spokane
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United States
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Tacoma
State/Province
Washington
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United States

12. IPD Sharing Statement

Learn more about this trial

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

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