heart attack myocardial infarction
Conditions
Interventions
The intervention group will be genotyped for the CYP2C19*2 and *3 alleles
within 48 hours after PCI. Carriers of a CYP2C19*2 or *3 allele will receive
prasugrel at a dosage of 10 mg once daily or ti
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) more than 21 years of age with symptoms of acute myocardial infarction of more than 30 minutes but less than 12 hours 2) performed primary PCI with stenting for STEMI
Exclusion criteria
Exclusion criteria: 1) unable to give informed consent or have a life expectancy of less than one year 2) active malignancy with increase in bleeding risk, in the investigator*s opinion 3) women who are known to be pregnant or who have given birth within the past 90 days or who are breastfeeding 4) having received thrombolytic therapy within the previous 24 hours or oral anticoagulants during the previous 7 days 5) severe renal function impairment needing dialysis 6) confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization 7) contraindication to anticoagulation or at increased bleeding risk, at the investigator*s opinion 8) cardiogenic shock (SBP 30 mins) or needing Intra-Aortic Balloon Pump (IABP) 9) history of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation 10) clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator*s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether the CYP2C19 genotype guided antiplatelet treatment strategy is not inferior to a treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in terms of the composite of death, recurrent myocardial infarction (MI), definite stent thrombosis, stroke and PLATO major bleeding at 1 year, in patients undergoing primary PCI for STEMI. If non-inferiority is proven, analysis will be performed for superiority. To determine whether the CYP2C19 genotype guided antiplatelet treatment strategy is superior to a treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in terms of a composite endpoint of PLATO major and minor bleeding. To assess the quality of life of patients and health-care resource use in both treatment groups i.e. the CYP2C19 genotype guided antiplatelet treatment and the treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel, to calculate Quality Adjusted Life Years (QALY*s) and net costs per life-year and QALY. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: To compare the efficacy of the CYP2C19 genotype guided antiplatelet treatment strategy versus the treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in terms of clinical outcome parameters taken separately or combinations of parameters i.e. death, cardiovascular death, cerebrovascular death, recurrent myocardial infarction (MI), definite stent thrombosis, probable stent thrombosis, possible stent thrombosis, urgent target vessel revascularisation (TVR), hospital admission for ACS or stroke at 30 days and 1 year, in patients undergoing primary PCI for STEMI. To compare the safety of the CYP2C19 genotype guided antiplatelet treatment strategy to the treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in terms of safety outcome parameters taken separately or combinations of these parameters i.e. (non-)CABG-related major bleeding, major bleeding, minor bleeding, life threatening bleeding, fatal bleeding, intracranial bleeding, bleed requiring transfusion at 30 days and 1 year in patients undergoing primary PCI for STEMI. Different bleeding classifications will be used i.e. TIMI, PLATO and BARC bleeding scales to make the study comparable to previous and future publications. To compare the CYP2C19 genotype guided antiplatelet treatment strategy (subdivided into patients included before protocol version 05, 16-02-2012 and patients included starting with protocol version 05, 16-02-2012) to a treatment strategy with either clopidogrel in all patients or a treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in terms of the composite of death, recurrent myocardial infarction (MI), definite stent thrombosis, stroke and PLATO major and minor bleeding at 30 days and 1 year, in patients undergoing primary PCI for STEMI. To compare the efficacy and safety of CYP2C19 genotype guided antiplatelet treatment strategy to the treatment strategy w | — |
Countries
Netherlands
Outcome results
None listed