- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02584660
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)
4. mai 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
114
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Montgomery, Alabama, Forente stater
-
-
Arizona
-
Chandler, Arizona, Forente stater
-
Phoenix, Arizona, Forente stater
-
Tucson, Arizona, Forente stater
-
-
California
-
Los Angeles, California, Forente stater
-
Sacramento, California, Forente stater
-
Sylmar, California, Forente stater
-
-
Connecticut
-
New Haven, Connecticut, Forente stater
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater
-
-
Florida
-
Pensacola, Florida, Forente stater
-
Tampa, Florida, Forente stater
-
-
Iowa
-
Davenport, Iowa, Forente stater
-
Iowa City, Iowa, Forente stater
-
-
Maryland
-
Baltimore, Maryland, Forente stater
-
-
Massachusetts
-
Springfield, Massachusetts, Forente stater
-
-
Michigan
-
Detroit, Michigan, Forente stater
-
Jackson, Michigan, Forente stater
-
Lansing, Michigan, Forente stater
-
Royal Oak, Michigan, Forente stater
-
-
Missouri
-
Saint Louis, Missouri, Forente stater
-
-
New Jersey
-
Atlantic City, New Jersey, Forente stater
-
Camden, New Jersey, Forente stater
-
-
New York
-
Brooklyn, New York, Forente stater
-
Buffalo, New York, Forente stater
-
New York, New York, Forente stater
-
Stony Brook, New York, Forente stater
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater
-
Charlotte, North Carolina, Forente stater
-
Durham, North Carolina, Forente stater
-
Winston-Salem, North Carolina, Forente stater
-
-
Ohio
-
Cincinnati, Ohio, Forente stater
-
Cleveland, Ohio, Forente stater
-
Toledo, Ohio, Forente stater
-
Zanesville, Ohio, Forente stater
-
-
Oregon
-
Portland, Oregon, Forente stater
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forente stater
-
Bethlehem, Pennsylvania, Forente stater
-
Philadelphia, Pennsylvania, Forente stater
-
Pittsburgh, Pennsylvania, Forente stater
-
West Reading, Pennsylvania, Forente stater
-
-
South Carolina
-
Charleston, South Carolina, Forente stater
-
-
Texas
-
Dallas, Texas, Forente stater
-
Fort Worth, Texas, Forente stater
-
Houston, Texas, Forente stater
-
-
Utah
-
Salt Lake City, Utah, Forente stater
-
-
Virginia
-
Charlottesville, Virginia, Forente stater
-
-
Washington
-
Bellingham, Washington, Forente stater
-
Everett, Washington, Forente stater
-
Spokane, Washington, Forente stater
-
Tacoma, Washington, Forente stater
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
|
Eksperimentell: 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.
|
Standard-of-care as per local protocol and defined by the medical team caring for the participant.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Duration of Hospitalization
Tidsramme: Up to Day 30
|
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.
|
Up to Day 30
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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
|
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.
|
Up to 7, 14, 30, and 90 Days
|
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
|
Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
|
Up to 7, 14, 30 and 90 Days
|
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
Tidsramme: Up to 30 and 90 Days
|
Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
|
Up to 30 and 90 Days
|
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
Tidsramme: Day 90
|
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.
|
Day 90
|
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
Tidsramme: Day 7
|
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.
|
Day 7
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. oktober 2015
Primær fullføring (Faktiske)
22. mars 2017
Studiet fullført (Faktiske)
22. mars 2017
Datoer for studieregistrering
Først innsendt
11. september 2015
Først innsendt som oppfylte QC-kriteriene
21. oktober 2015
Først lagt ut (Anslag)
22. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i luftveiene
- Lungesykdommer
- Sykdomsattributter
- Embolisme og trombose
- Nødsituasjoner
- Embolisme
- Lungeemboli
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Proteasehemmere
- Faktor Xa-hemmere
- Antitrombiner
- Serinproteinasehemmere
- Antikoagulanter
- Rivaroksaban
Andre studie-ID-numre
- CR107694
- 39039039APE4001 (Annen identifikator: Janssen Scientific Affairs, LLC)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungeemboli
-
Beijing Aerospace General HospitalFullførtSutur | Videoassistert thorakoskopisk kirurgi | Nodule, Solitary PulmonaryKina
-
Shenzhen Third People's HospitalFullførtPerifer Solitary Pulmonary Nodule eller TuberculomaKina
Kliniske studier på Rivaroxaban
-
Korea University Anam HospitalRekrutteringAtrieflimmer | Antikoagulerende bivirkningKorea, Republikken
-
Doasense GmbHAktiv, ikke rekrutterendeAntikoagulerende terapiTyskland
-
The Affiliated Hospital of Qingdao UniversityFullført
-
BayerJanssen R&D, L.L.C.Fullført
-
Addpharma Inc.FullførtEmbolisme og tromboseKorea, Republikken
-
BayerFullførtEmbolisme, atrieflimmer og venetromboseJapan
-
BayerJanssen Research & Development, LLCFullførtKoronararteriesykdom | Hjerte-og karsykdommerBelgia, Nederland
-
BayerFullførtVenøs tromboembolismeForente stater, Canada
-
BayerJanssen Research & Development, LLCFullført