ST elevation myocardial infarction STEMI
Conditions
Interventions
Patients will be randomly assigned (1:1) in the ambulance to receive 60mg
prasugrel loading dose in a whole tablet or crushed tablet.
Sponsors
Research Maatschap Cardiologen Rotterdam Zuid
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Consecutive patients with STEMI planned for primary PCI - Deferred written informed consent within 4 hours after initial treatment - 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
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. However, patients on maintenance dose clopidogrel for at least 7 days are included in the study. See appendix A (patient on clopidogrel maintenance dose) - 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 or 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of crushed vs. integral tablets of prasugrel loading dose treatment by comparing the percentage of STEMI patients reaching the independent co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a >=70% ST-segment elevation resolution 60min post-PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy and safety crushed vs. integral tablets of prasugrel loading dose treatment by assessing the following endpoints: 1. Efficacy analysis of independent primary endpoints in the complete randomized study population, as well as in the study population who underwent primary PCI at index procedure 2. Composite of death, MI, and urgent revascularization inhospital, at 30 days and 12 months, as well as individual endpoints of above composite endpoint 3. Composite of death, MI, stroke, urgent revascularization, stent thrombosis, and thrombotic bail-out with GPIIb/IIIa antagonists inhospital, at 30 days and 12 months, as well as individual endpoints of above composite endpoint 4. Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration, with exploratory analysis of pharmacodynamics among patients receiving morphine 5. >=70% ST-segment resolution pre-PCI and directly after PCI 6. TIMI flow grade 3 at end of procedure, as well as corrected TIMI frame count, TIMI myocardial perfusion grade, and modified TIMI thrombus grading at angiography, pre and post PCI* 7. - Interaction and sensitivity analysis for independent primary endpoints, and secondary endpoints based on clopidogrel naïve vs clopidogrel MD vs. complete population 8. - Interaction analysis of independent primary endpoints. and secondary endpoints depending whether patients received morphine 9. Safety: Bleeding complication (TRITON TIMI-38 and BARC bleeding definition), within the first 48 hours, during 30 days and 12 months of active treatment 10. Safety: Composite of Bleeding, death, MI, and stroke within the first 48 hours, during 30 days and 12 months of active treatment A secondary efficacy analysis dataset will be performed in: a) All randomized patients b) All STEMI patients who underwent primary PCI | — |
Countries
Netherlands
Outcome results
None listed