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

6. maj 2021 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

729

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Rotterdam, Holland, 3015 CE
        • Erasmus Medical Center
      • Rotterdam, Holland, 3079 DZ
        • Maasstadziekenhuis

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:

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

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
Aktiv komparator: Uncrushed
6 Integral tablets Prasugrel as loading dose
loading dose of 6 integral tablets of 10mg Prasugrel
Andre navne:
  • 6 Integral tablets of Prasugrel 10mg
Eksperimentel: Crushed
6 Crushed tablets Prasugrel as loading dose
loading dose of 6 crushed tablets 10mg Prasugrel
Andre navne:
  • 6 Crushed tablets of Prasugrel 10mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: directly post PCI
TIMI flow grade 3 at end of procedure.
directly post PCI
Myocardial Blush at the start and end of the procedure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: upto 72 hours after randomisation
PD of each group among patients stratified for morphine treatment
upto 72 hours after randomisation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: George Vlachojannis, MD, PhD, Maasstadziekenhuis
  • Studieleder: Pieter C Smits, MD, PhD, Maasstadziekenhuis
  • Studiestol: Nicolas van Mieghem, MD, PhD, Erasmus Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

28. november 2017

Primær færdiggørelse (Faktiske)

1. maj 2021

Studieafslutning (Faktiske)

1. maj 2021

Datoer for studieregistrering

Først indsendt

6. september 2017

Først indsendt, der opfyldte QC-kriterier

25. september 2017

Først opslået (Faktiske)

28. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2017-40

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Hjerte-kar-sygdomme

Kliniske forsøg med Prasugrel (Integral tablets)

3
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