ST elevated Myocardial infarction (STEMI) MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Efient
Product Name: Efient
Product Code: B01AC22
Pharmaceutical Form: Film-coated tablet
Trade Name: Efient
Product Name: Efient
Product Code: B01AC22
Pharmaceutical Form: Film-coated ta
Sponsors
Research Maatschap Cardiologen Rijnmond Zuid
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 374
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, or prasugrel. Patients on maintenance dose clopidogrel for at least 7 days are included. - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 60min post-PCI. ;Secondary Objective: - level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration - platelet reactivity, at each time point as well as over time - rates of HPR - exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine - Time –relationship (from symptom onset to 1st dose intake) on each primary - Time –relationship (from 1st dose intake to/ angiography and to ECG 1h after PCI) on each primary - =70% ST-segment resolution pre-PCI and directly after PCI - Corrected TIMI frame count (cTFC) at angiography, pre and post PCI - TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI - TIMI myocardial blush grade at angiography, pre and post PCI - TIMI flow grade 3 at end of procedure - Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in-hospital, during 30 days and 12 months of treatment ;Primary end point(s): 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 60min post-PCI;Timepoint(s) of evaluation of this end point: 60 minutes post-PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 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 Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI Complete (= 70%) ST-segment elevation resolution pre -PCI and directly post-PCI Corrected TIMI frame count (cTFC) at angiography, pre and post PCI TIMI myocardial perfusion grade (TMPG) at angiography, pre and 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 60min post-PCI Time from first dose intake to ECG correlated to =70% ST-segment elevation resolution 60min post-PCI and time from randomization to initial angiography correlated to TIMI flow grade 3 of MI culprit vessel TIMI flow grade 3 at end of procedure Myocardial blush at the start and end of the procedure Maximum CK, and CK-MB levels PRU measurements at first medical contact, beginning and end of PCI, as well as 4 after drug administration PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration Percentage of patients with PRU values over HPR threshold PRU of each group among patients stratified for morphine treatment Percentage of patients having a bleeding event defined by the TRITON TIMI-38 and BARC bleeding definitions, within the first 48 hours, (i.e. primary safety endpoint) during 30 days and 12 months of study Interaction analysis on primary and secondary endpoints depending on stratified randomization group (clopidogrel naïve vs. clopidogrel MD) A secondary efficacy an | — |
Countries
Netherlands
Contacts
Public ContactRia van Vliet - project manager
Research Maatschap Cardiologen Rijnmond Zuid
Outcome results
None listed