Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

6 maj 2021 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

729

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Uncrushed
6 Integral tablets Prasugrel as loading dose
loading dose of 6 integral tablets of 10mg Prasugrel
Andra namn:
  • 6 Integral tablets of Prasugrel 10mg
Experimentell: Crushed
6 Crushed tablets Prasugrel as loading dose
loading dose of 6 crushed tablets 10mg Prasugrel
Andra namn:
  • 6 Crushed tablets of Prasugrel 10mg

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 november 2017

Primärt slutförande (Faktisk)

1 maj 2021

Avslutad studie (Faktisk)

1 maj 2021

Studieregistreringsdatum

Först inskickad

6 september 2017

Först inskickad som uppfyllde QC-kriterierna

25 september 2017

Första postat (Faktisk)

28 september 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 maj 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2017-40

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Prasugrel (Integral tablets)

3
Prenumerera