A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)
2018년 5월 4일 업데이트: Janssen Scientific Affairs, LLC
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
114
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Montgomery, Alabama, 미국
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Arizona
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Chandler, Arizona, 미국
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Phoenix, Arizona, 미국
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Tucson, Arizona, 미국
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California
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Los Angeles, California, 미국
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Sacramento, California, 미국
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Sylmar, California, 미국
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Connecticut
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New Haven, Connecticut, 미국
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District of Columbia
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Washington, District of Columbia, 미국
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Florida
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Pensacola, Florida, 미국
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Tampa, Florida, 미국
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Iowa
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Davenport, Iowa, 미국
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Iowa City, Iowa, 미국
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Maryland
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Baltimore, Maryland, 미국
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Massachusetts
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Springfield, Massachusetts, 미국
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Michigan
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Detroit, Michigan, 미국
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Jackson, Michigan, 미국
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Lansing, Michigan, 미국
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Royal Oak, Michigan, 미국
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Missouri
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Saint Louis, Missouri, 미국
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New Jersey
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Atlantic City, New Jersey, 미국
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Camden, New Jersey, 미국
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New York
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Brooklyn, New York, 미국
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Buffalo, New York, 미국
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New York, New York, 미국
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Stony Brook, New York, 미국
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North Carolina
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Chapel Hill, North Carolina, 미국
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Charlotte, North Carolina, 미국
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Durham, North Carolina, 미국
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Winston-Salem, North Carolina, 미국
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Ohio
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Cincinnati, Ohio, 미국
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Cleveland, Ohio, 미국
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Toledo, Ohio, 미국
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Zanesville, Ohio, 미국
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Oregon
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Portland, Oregon, 미국
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Pennsylvania
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Allentown, Pennsylvania, 미국
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Bethlehem, Pennsylvania, 미국
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Philadelphia, Pennsylvania, 미국
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Pittsburgh, Pennsylvania, 미국
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West Reading, Pennsylvania, 미국
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South Carolina
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Charleston, South Carolina, 미국
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Texas
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Dallas, Texas, 미국
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Fort Worth, Texas, 미국
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Houston, Texas, 미국
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Utah
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Salt Lake City, Utah, 미국
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Virginia
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Charlottesville, Virginia, 미국
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Washington
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Bellingham, Washington, 미국
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Everett, Washington, 미국
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Spokane, Washington, 미국
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Tacoma, Washington, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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실험적: 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.
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Standard-of-care as per local protocol and defined by the medical team caring for the participant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Duration of Hospitalization
기간: Up to Day 30
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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.
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Up to Day 30
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
기간: Up to 7, 14, 30, and 90 Days
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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.
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Up to 7, 14, 30, and 90 Days
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Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding
기간: Up to 7, 14, 30 and 90 Days
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Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
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Up to 7, 14, 30 and 90 Days
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Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
기간: Up to 30 and 90 Days
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Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
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Up to 30 and 90 Days
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Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
기간: Day 90
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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.
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Day 90
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Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
기간: Day 7
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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.
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Day 7
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 10월 15일
기본 완료 (실제)
2017년 3월 22일
연구 완료 (실제)
2017년 3월 22일
연구 등록 날짜
최초 제출
2015년 9월 11일
QC 기준을 충족하는 최초 제출
2015년 10월 21일
처음 게시됨 (추정)
2015년 10월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 4일
마지막으로 확인됨
2018년 5월 1일
추가 정보
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