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CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI (CompareCrush)

6 de mayo de 2021 actualizado por: Maasstad Hospital

COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions

The studys evaluates the effect of prehospital administration of crushed tablets of Prasugrel loading dose (in addition to ASA and standard care) versus uncrushed tablets of Prasugrel loading dose on efficacy and safety as well as pharmacodynamics as measured by platelet reactivity using VerifyNow.

Descripción general del estudio

Descripción detallada

The study is a two-centre, randomized, 1:1 trial comparing prehospital prasugrel initiation therapy between crushed vs. uncrushed prasugrel tablets on efficacy and safety as well as pharmacodynamics in STEMI patients.

Patients with STEMI planned for primary PCI will be screened and, if inclusion criteria are met, included at first medical contact (paramedics). After enrolment, patients will be randomly assigned (1:1) to receive 60mg prasugrel loading dose by ingesting integral or crushed tablets.

The follow-up duration is 12 months, i.e. clinical outcomes will be analysed in-hospital, at 30 days, and 12 months

Tipo de estudio

Intervencionista

Inscripción (Actual)

729

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

      • Rotterdam, Países Bajos, 3015 CE
        • Erasmus Medical Center
      • Rotterdam, Países Bajos, 3079 DZ
        • Maasstadziekenhuis

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:

Consecutive patients with STEMI planned for primary PCI:

  • Deferred written informed consent within 4 hours after prasugrel loading dose
  • Adult men and women aged at least 18 years
  • Symptoms of acute MI of more than 30 min but less than 6 hours
  • New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads

Exclusion Criteria:

  • Contraindication to prasugrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed, history of any CVA including TIA, moderate to severe hepatic impairment, GI bleed within the past 6 months, major surgery within past 4 weeks)
  • Patient who has received loading dose of clopidogrel or ticagrelor for the index event or are on chronic treatment of ticagrelor, or prasugrel. However, patients on maintenance dose clopidogrel for at least 7 days are included in the study (see appendix A).
  • Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring chronic therapy)
  • Planned fibrinolytic treatment
  • Patient requiring dialysis
  • Known, clinically important thrombocytopenia
  • Known clinically important anaemia
  • Known pregnancy or lactation
  • Need for a concomitant systemic therapy with strong inhibitors or strong inducers of CYP3A
  • Condition which may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock with severe hemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up)
  • Patient unable to swallow oral medication (i.e. intubated patients)
  • Patient who have not received prasugrel loading dose in the ambulance
  • Patient who vomited after randomization / receiving the loading dose prasugrel

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
Comparador activo: Uncrushed
6 Integral tablets Prasugrel as loading dose
loading dose of 6 integral tablets of 10mg Prasugrel
Otros nombres:
  • 6 Integral tablets of Prasugrel 10mg
Experimental: Crushed
6 Crushed tablets Prasugrel as loading dose
loading dose of 6 crushed tablets 10mg Prasugrel
Otros nombres:
  • 6 Crushed tablets of Prasugrel 10mg

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Co-primary endpoint is the percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment resolution directly post-PCI
Periodo de tiempo: directly post PCI
To assess the efficacy of crushed vs. integral tablets of prasugrel loading dose treatment by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment elevation resolution directly post-PCI.
directly post PCI

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months
Periodo de tiempo: upto 72 hours after randomisation, at 30 days and 12 months.
Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during inhospital stay, 30 days and 12 months of study
upto 72 hours after randomisation, at 30 days and 12 months.
Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study
Periodo de tiempo: 30 days and 12 months
Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study
30 days and 12 months
Individual endpoints during inhospital, at 30 days and 12 months of study
Periodo de tiempo: upto 72 hours after randomisation, at 30 days and 12 months.
Percentage of patients presenting with any of the individual endpoints during inhospital, 30 days and 12 months of study
upto 72 hours after randomisation, at 30 days and 12 months.
Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
Periodo de tiempo: directly post PCI
Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
directly post PCI
Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
Periodo de tiempo: pre-PCI and 60 min post-PCI
Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
pre-PCI and 60 min post-PCI
Corrected TIMI frame count (cTFC) at angiography, pre and post PCI.
Periodo de tiempo: pre PCI, directly post PCI
Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
pre PCI, directly post PCI
TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
Periodo de tiempo: pre PCI, directly post PCI
TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
pre PCI, directly post PCI
Time-relationship (from symptom onset to 1st dose intake) on each co-primary
Periodo de tiempo: directly post-PCI
Time from symptom onset to 1st dose intake correlated to TIMI flow grade 3 of MI culprit vessel at initial angiography and on ≥70% ST-segment elevation resolution directly post-PCI
directly post-PCI
Time-relationship (from 1st dose intake to ECG/ angiography) on each co-primary
Periodo de tiempo: directly post-PCI
Time from first dose intake to ECG correlated to ≥70% ST-segment elevation resolution directly post-PCI and time from randomization to initial angiography correlated to TIMI flow grade 3 of MI culprit vessel
directly post-PCI
TIMI flow grade 3 at end of procedure.
Periodo de tiempo: directly post PCI
TIMI flow grade 3 at end of procedure.
directly post PCI
Myocardial Blush at the start and end of the procedure
Periodo de tiempo: pre PCI, directly post PCI
Myocardial Blush at the start and end of the procedure
pre PCI, directly post PCI
Maximum CK, and CK-MB levels
Periodo de tiempo: upto 72 hours after randomisation
Maximum CK, and CK-MB levels
upto 72 hours after randomisation
Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
Periodo de tiempo: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
Platelet reactivity, at each time point as well as over time
Periodo de tiempo: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration
at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
Rates of HPR
Periodo de tiempo: upto 72 hours after randomisation
Percentage of patients with PRU values over HPR threshold
upto 72 hours after randomisation
Exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine
Periodo de tiempo: upto 72 hours after randomisation
PD of each group among patients stratified for morphine treatment
upto 72 hours after randomisation

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: George Vlachojannis, MD, PhD, Maasstadziekenhuis
  • Director de estudio: Pieter C Smits, MD, PhD, Maasstadziekenhuis
  • Silla de estudio: Nicolas van Mieghem, MD, PhD, Erasmus Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

28 de noviembre de 2017

Finalización primaria (Actual)

1 de mayo de 2021

Finalización del estudio (Actual)

1 de mayo de 2021

Fechas de registro del estudio

Enviado por primera vez

6 de septiembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

25 de septiembre de 2017

Publicado por primera vez (Actual)

28 de septiembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2021

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

6 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2017-40

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Enfermedades cardiovasculares

Ensayos clínicos sobre Prasugrel (Integral tablets)

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