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- Klinische proef NCT03296540
CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI (CompareCrush)
COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
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Rotterdam, Nederland, 3015 CE
- Erasmus Medical Center
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Rotterdam, Nederland, 3079 DZ
- Maasstadziekenhuis
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Uncrushed
6 Integral tablets Prasugrel as loading dose
|
loading dose of 6 integral tablets of 10mg Prasugrel
Andere namen:
|
Experimenteel: Crushed
6 Crushed tablets Prasugrel as loading dose
|
loading dose of 6 crushed tablets 10mg Prasugrel
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months
Tijdsspanne: 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
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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
Tijdsspanne: 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
Tijdsspanne: 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
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upto 72 hours after randomisation, at 30 days and 12 months.
|
Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
Tijdsspanne: directly post PCI
|
Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
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directly post PCI
|
Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
Tijdsspanne: pre-PCI and 60 min post-PCI
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Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
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pre-PCI and 60 min post-PCI
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Corrected TIMI frame count (cTFC) at angiography, pre and post PCI.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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TIMI flow grade 3 at end of procedure.
Tijdsspanne: directly post PCI
|
TIMI flow grade 3 at end of procedure.
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directly post PCI
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Myocardial Blush at the start and end of the procedure
Tijdsspanne: pre PCI, directly post PCI
|
Myocardial Blush at the start and end of the procedure
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pre PCI, directly post PCI
|
Maximum CK, and CK-MB levels
Tijdsspanne: upto 72 hours after randomisation
|
Maximum CK, and CK-MB levels
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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
Tijdsspanne: 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
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at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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Platelet reactivity, at each time point as well as over time
Tijdsspanne: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration
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at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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Rates of HPR
Tijdsspanne: upto 72 hours after randomisation
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Percentage of patients with PRU values over HPR threshold
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upto 72 hours after randomisation
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Exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine
Tijdsspanne: upto 72 hours after randomisation
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PD of each group among patients stratified for morphine treatment
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upto 72 hours after randomisation
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: George Vlachojannis, MD, PhD, Maasstadziekenhuis
- Studie directeur: Pieter C Smits, MD, PhD, Maasstadziekenhuis
- Studie stoel: Nicolas van Mieghem, MD, PhD, Erasmus Medical Center
Publicaties en nuttige links
Algemene publicaties
- Vlachojannis GJ, Wilschut JM, Vogel RF, Lemmert ME, Delewi R, Diletti R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial. Circulation. 2020 Dec 15;142(24):2316-2328. doi: 10.1161/CIRCULATIONAHA.120.051532. Epub 2020 Oct 14.
- Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J. 2020 Jun;224:10-16. doi: 10.1016/j.ahj.2020.03.005. Epub 2020 Mar 11.
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2017-40
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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