- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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-
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Rotterdam, Holandsko, 3015 CE
- Erasmus Medical Center
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Rotterdam, Holandsko, 3079 DZ
- Maasstadziekenhuis
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: Uncrushed
6 Integral tablets Prasugrel as loading dose
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loading dose of 6 integral tablets of 10mg Prasugrel
Ostatní jména:
|
Experimentální: Crushed
6 Crushed tablets Prasugrel as loading dose
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loading dose of 6 crushed tablets 10mg Prasugrel
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
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
Časové okno: 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.
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directly post PCI
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months
Časové okno: 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.
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Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study
Časové okno: 30 days and 12 months
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Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study
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30 days and 12 months
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Individual endpoints during inhospital, at 30 days and 12 months of study
Časové okno: upto 72 hours after randomisation, at 30 days and 12 months.
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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.
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Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
Časové okno: directly post PCI
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Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
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directly post PCI
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Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
Časové okno: 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.
Časové okno: pre PCI, directly post PCI
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Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
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pre PCI, directly post PCI
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TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
Časové okno: pre PCI, directly post PCI
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TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
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pre PCI, directly post PCI
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Time-relationship (from symptom onset to 1st dose intake) on each co-primary
Časové okno: directly post-PCI
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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
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directly post-PCI
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Time-relationship (from 1st dose intake to ECG/ angiography) on each co-primary
Časové okno: directly post-PCI
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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
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directly post-PCI
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TIMI flow grade 3 at end of procedure.
Časové okno: directly post PCI
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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
Časové okno: pre PCI, directly post PCI
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Myocardial Blush at the start and end of the procedure
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pre PCI, directly post PCI
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Maximum CK, and CK-MB levels
Časové okno: upto 72 hours after randomisation
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Maximum CK, and CK-MB levels
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upto 72 hours after randomisation
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Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
Časové okno: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: George Vlachojannis, MD, PhD, Maasstadziekenhuis
- Ředitel studie: Pieter C Smits, MD, PhD, Maasstadziekenhuis
- Studijní židle: Nicolas van Mieghem, MD, PhD, Erasmus Medical Center
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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