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| Name | Class |
|---|---|
| MicroPort Orthopedics Inc. | INDUSTRY |
| Daiichi Sankyo | INDUSTRY |
| Research Maatschap Cardiologen Rotterdam Zuid | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncrushed | Active Comparator | 6 Integral tablets Prasugrel as loading dose |
|
| Crushed | Experimental | 6 Crushed tablets Prasugrel as loading dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel (Crushed tablets) | Drug | loading dose of 6 crushed tablets 10mg Prasugrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, 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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Inclusion Criteria:
Consecutive patients with STEMI planned for primary PCI:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Vlachojannis, MD, PhD | Maasstadziekenhuis | Principal Investigator |
| Pieter C Smits, MD, PhD | Maasstadziekenhuis | Study Director |
| Nicolas van Mieghem, MD, PhD | Erasmus Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands | |||
| Maasstadziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33315489 | Derived | 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. | |
| 32272255 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 6, 2022 | |
| Reset | Jul 27, 2023 | |
| Release | Feb 8, 2024 | |
| Reset | Jul 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 6, 2022 | Jul 27, 2023 | |||
| Feb 8, 2024 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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Crushed versus uncrushed tablets Prasugrel loading dose
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| Prasugrel (Integral tablets) | Drug | loading dose of 6 integral tablets of 10mg Prasugrel |
|
|
| Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study | 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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. | TIMI flow grade 3 at end of procedure. | directly post PCI |
| Myocardial Blush at the start and end of the procedure | Myocardial Blush at the start and end of the procedure | pre PCI, directly post PCI |
| Maximum CK, and CK-MB levels | 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 | 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 | 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 | 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 | PD of each group among patients stratified for morphine treatment | upto 72 hours after randomisation |
| Rotterdam |
| 3079 DZ |
| Netherlands |
| Derived |
| 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. |
| Jul 26, 2024 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |