- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02584660
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)
4. maj 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
114
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Montgomery, Alabama, Forenede Stater
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Arizona
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Chandler, Arizona, Forenede Stater
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Phoenix, Arizona, Forenede Stater
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Tucson, Arizona, Forenede Stater
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California
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Los Angeles, California, Forenede Stater
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Sacramento, California, Forenede Stater
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Sylmar, California, Forenede Stater
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Connecticut
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New Haven, Connecticut, Forenede Stater
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District of Columbia
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Washington, District of Columbia, Forenede Stater
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Florida
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Pensacola, Florida, Forenede Stater
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Tampa, Florida, Forenede Stater
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Iowa
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Davenport, Iowa, Forenede Stater
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Iowa City, Iowa, Forenede Stater
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Maryland
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Baltimore, Maryland, Forenede Stater
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Massachusetts
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Springfield, Massachusetts, Forenede Stater
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Michigan
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Detroit, Michigan, Forenede Stater
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Jackson, Michigan, Forenede Stater
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Lansing, Michigan, Forenede Stater
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Royal Oak, Michigan, Forenede Stater
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Missouri
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Saint Louis, Missouri, Forenede Stater
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New Jersey
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Atlantic City, New Jersey, Forenede Stater
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Camden, New Jersey, Forenede Stater
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New York
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Brooklyn, New York, Forenede Stater
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Buffalo, New York, Forenede Stater
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New York, New York, Forenede Stater
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Stony Brook, New York, Forenede Stater
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater
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Charlotte, North Carolina, Forenede Stater
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Durham, North Carolina, Forenede Stater
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Winston-Salem, North Carolina, Forenede Stater
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Ohio
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Cincinnati, Ohio, Forenede Stater
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Cleveland, Ohio, Forenede Stater
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Toledo, Ohio, Forenede Stater
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Zanesville, Ohio, Forenede Stater
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Oregon
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater
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Bethlehem, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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Pittsburgh, Pennsylvania, Forenede Stater
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West Reading, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Texas
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Dallas, Texas, Forenede Stater
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Fort Worth, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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Utah
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Salt Lake City, Utah, Forenede Stater
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Virginia
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Charlottesville, Virginia, Forenede Stater
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Washington
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Bellingham, Washington, Forenede Stater
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Everett, Washington, Forenede Stater
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Spokane, Washington, Forenede Stater
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Tacoma, Washington, Forenede Stater
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean Duration of Hospitalization
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. oktober 2015
Primær færdiggørelse (Faktiske)
22. marts 2017
Studieafslutning (Faktiske)
22. marts 2017
Datoer for studieregistrering
Først indsendt
11. september 2015
Først indsendt, der opfyldte QC-kriterier
21. oktober 2015
Først opslået (Skøn)
22. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Luftvejssygdomme
- Lungesygdomme
- Sygdomsegenskaber
- Embolisme og trombose
- Nødsituationer
- Embolisme
- Lungeemboli
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Proteasehæmmere
- Faktor Xa-hæmmere
- Antithrombiner
- Serinproteinasehæmmere
- Antikoagulanter
- Rivaroxaban
Andre undersøgelses-id-numre
- CR107694
- 39039039APE4001 (Anden identifikator: Janssen Scientific Affairs, LLC)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rivaroxaban
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Korea University Anam HospitalRekrutteringAtrieflimren | Antikoagulerende bivirkningKorea, Republikken
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China National Center for Cardiovascular DiseasesIkke rekrutterer endnuSlag | Atrieflimren | Større uønskede hjertehændelser | Antikoagulerende bivirkning
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BayerAfsluttet
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The Affiliated Hospital of Qingdao UniversityAfsluttet
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BayerJanssen R&D, L.L.C.Afsluttet
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Centre Hospitalier Universitaire de Saint EtienneAfsluttetSund og raskFrankrig
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University Hospital, GrenobleAfsluttet
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BayerAfsluttetVenøs tromboembolismeForenede Stater, Canada
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BayerJanssen Research & Development, LLCAfsluttetKoronararteriesygdom | Kardiovaskulær sygdomBelgien, Holland
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BayerAfsluttet