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A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)

4 de mayo de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

114

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Montgomery, Alabama, Estados Unidos
    • Arizona
      • Chandler, Arizona, Estados Unidos
      • Phoenix, Arizona, Estados Unidos
      • Tucson, Arizona, Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos
      • Sacramento, California, Estados Unidos
      • Sylmar, California, Estados Unidos
    • Connecticut
      • New Haven, Connecticut, Estados Unidos
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos
    • Florida
      • Pensacola, Florida, Estados Unidos
      • Tampa, Florida, Estados Unidos
    • Iowa
      • Davenport, Iowa, Estados Unidos
      • Iowa City, Iowa, Estados Unidos
    • Maryland
      • Baltimore, Maryland, Estados Unidos
    • Massachusetts
      • Springfield, Massachusetts, Estados Unidos
    • Michigan
      • Detroit, Michigan, Estados Unidos
      • Jackson, Michigan, Estados Unidos
      • Lansing, Michigan, Estados Unidos
      • Royal Oak, Michigan, Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos
    • New Jersey
      • Atlantic City, New Jersey, Estados Unidos
      • Camden, New Jersey, Estados Unidos
    • New York
      • Brooklyn, New York, Estados Unidos
      • Buffalo, New York, Estados Unidos
      • New York, New York, Estados Unidos
      • Stony Brook, New York, Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos
      • Charlotte, North Carolina, Estados Unidos
      • Durham, North Carolina, Estados Unidos
      • Winston-Salem, North Carolina, Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
      • Cleveland, Ohio, Estados Unidos
      • Toledo, Ohio, Estados Unidos
      • Zanesville, Ohio, Estados Unidos
    • Oregon
      • Portland, Oregon, Estados Unidos
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos
      • Bethlehem, Pennsylvania, Estados Unidos
      • Philadelphia, Pennsylvania, Estados Unidos
      • Pittsburgh, Pennsylvania, Estados Unidos
      • West Reading, Pennsylvania, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos
      • Fort Worth, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
    • Utah
      • Salt Lake City, Utah, Estados Unidos
    • Virginia
      • Charlottesville, Virginia, Estados Unidos
    • Washington
      • Bellingham, Washington, Estados Unidos
      • Everett, Washington, Estados Unidos
      • Spokane, Washington, Estados Unidos
      • Tacoma, Washington, Estados Unidos

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Rivaroxaban
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.
Experimental: 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.
Droga: Standard-of-care
Standard-of-care as per local protocol and defined by the medical team caring for the participant.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Duration of Hospitalization
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Scientific Affairs, LLC

Colaboradores

Bayer

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de octubre de 2015

Finalización primaria (Actual)

22 de marzo de 2017

Finalización del estudio (Actual)

22 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

21 de octubre de 2015

Publicado por primera vez (Estimar)

22 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR107694
  • 39039039APE4001 (Otro identificador: Janssen Scientific Affairs, LLC)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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