Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

6. mai 2021 oppdatert av: 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.

Studieoversikt

Detaljert 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

Studietype

Intervensjonell

Registrering (Faktiske)

729

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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:

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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)

28. november 2017

Primær fullføring (Faktiske)

1. mai 2021

Studiet fullført (Faktiske)

1. mai 2021

Datoer for studieregistrering

Først innsendt

6. september 2017

Først innsendt som oppfylte QC-kriteriene

25. september 2017

Først lagt ut (Faktiske)

28. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2017-40

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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 Prasugrel (Integral tablets)

3
Abonnere