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Pulmonary EmbolismPhase 4MERCURY PENCT02584660

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

A Phase 4 study testing Rivaroxaban and Standard-of-care in people with Pulmonary Embolism, run by Janssen Scientific Affairs, LLC at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
Rivaroxaban and Standard-of-care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
50 sitesUnited States
Study dates
15 Oct 2015to 22 Mar 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Atlantic City, New Jersey

  • Study site

    Baltimore, Maryland

  • Study site

    Bellingham, Washington

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Brooklyn, New York

  • Study site

    Buffalo, New York

  • Study site

    Camden, New Jersey

  • Study site

    Chandler, Arizona

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Everett, Washington

  • Study site

    Fort Worth, Texas

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Jackson, Michigan

  • Study site

    Lansing, Michigan

  • Study site

    Los Angeles, California

  • Study site

    Montgomery, Alabama

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Royal Oak, Michigan

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Massachusetts

  • Study site

    St Louis, Missouri

  • Study site

    Stony Brook, New York

  • Study site

    Sylmar, California

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Reading, Pennsylvania

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zanesville, Ohio

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Rivaroxaban, Standard-of-care
Keywords
Rivaroxaban, JNJ39039039, Pulmonary embolism
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    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.

  • Standard-of-careDrug

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

Study groups in NCT02584660
Study groupRoleWhat they receive
RivaroxabanExperimentalParticipants 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.
Receives: Drug: Rivaroxaban
local Standard-of-careExperimentalParticipants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Receives: Drug: Standard-of-care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 30

Secondary outcomes (5)

  1. 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.

    Measured: Up to 7, 14, 30, and 90 Days

  2. 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.

    Measured: Up to 7, 14, 30 and 90 Days

  3. 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.

    Measured: Up to 30 and 90 Days

  4. 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.

    Measured: Day 90

  5. 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.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study start15 Oct 2015
  3. Primary completion22 Mar 2017
  4. Study completion22 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584660
Sponsor's protocol ID
CR107694
Other IDs
39039039APE4001
Acronym
MERCURY PE
Status last verified
May 2018
First submitted
11 Sep 2015
Last updated
1 Jun 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban and Standard-of-care in people with Pulmonary Embolism, run by Janssen Scientific Affairs, LLC at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Duration of Hospitalization (time frame: Up to Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.

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