A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)
2018年5月4日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
114
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Montgomery、Alabama、美国
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Arizona
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Chandler、Arizona、美国
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Phoenix、Arizona、美国
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Tucson、Arizona、美国
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California
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Los Angeles、California、美国
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Sacramento、California、美国
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Sylmar、California、美国
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Connecticut
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New Haven、Connecticut、美国
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District of Columbia
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Washington、District of Columbia、美国
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Florida
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Pensacola、Florida、美国
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Tampa、Florida、美国
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Iowa
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Davenport、Iowa、美国
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Iowa City、Iowa、美国
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Maryland
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Baltimore、Maryland、美国
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Massachusetts
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Springfield、Massachusetts、美国
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Michigan
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Detroit、Michigan、美国
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Jackson、Michigan、美国
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Lansing、Michigan、美国
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Royal Oak、Michigan、美国
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Missouri
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Saint Louis、Missouri、美国
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New Jersey
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Atlantic City、New Jersey、美国
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Camden、New Jersey、美国
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New York
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Brooklyn、New York、美国
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Buffalo、New York、美国
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New York、New York、美国
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Stony Brook、New York、美国
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North Carolina
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Chapel Hill、North Carolina、美国
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Charlotte、North Carolina、美国
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Durham、North Carolina、美国
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Winston-Salem、North Carolina、美国
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Ohio
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Cincinnati、Ohio、美国
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Cleveland、Ohio、美国
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Toledo、Ohio、美国
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Zanesville、Ohio、美国
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Oregon
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Portland、Oregon、美国
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Pennsylvania
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Allentown、Pennsylvania、美国
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Bethlehem、Pennsylvania、美国
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Philadelphia、Pennsylvania、美国
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Pittsburgh、Pennsylvania、美国
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West Reading、Pennsylvania、美国
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South Carolina
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Charleston、South Carolina、美国
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Texas
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Dallas、Texas、美国
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Fort Worth、Texas、美国
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Houston、Texas、美国
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Utah
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Salt Lake City、Utah、美国
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Virginia
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Charlottesville、Virginia、美国
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Washington
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Bellingham、Washington、美国
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Everett、Washington、美国
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Spokane、Washington、美国
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Tacoma、Washington、美国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Duration of Hospitalization
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年10月15日
初级完成 (实际的)
2017年3月22日
研究完成 (实际的)
2017年3月22日
研究注册日期
首次提交
2015年9月11日
首先提交符合 QC 标准的
2015年10月21日
首次发布 (估计)
2015年10月22日
研究记录更新
最后更新发布 (实际的)
2018年6月1日
上次提交的符合 QC 标准的更新
2018年5月4日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.