ST-segment myocardial infarction (STEMI) followed by immediate percutaneous coronary intervention with stent implantation
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Tablet
Trade Name: Efient
Pharmaceutical Form: Tablet
Trade Name: clopidogrel
Pharmaceutical Form: Tablet
Trade Name: Brilique
Pharmaceutical Form: Tablet
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
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 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 1900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
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 = 80mmHg for >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 |
|---|---|
| Main Objective: 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 (control group) in terms of the composite of death, recurrent 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 genotype guided treatment strategy is superior to a treatment of the control group 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 to calculate Quality Adjusted Life Years (QALY’s) and net costs per life-year and QALY. ;Timepoint(s) of evaluation of this end point: At one year following PCI.;Secondary Objective: To compare the safety and efficacy of the genotype guided treatment strategy versus the treatment of the control group in terms of clinical and safety outcome parameters taken separately or combinations of parameters. To compare the genotype guided 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 in terms of the composite of death, recurrent MI, definite stent thrombosis, stroke and PLATO major and minor bleeding. To compare the efficacy and safety of CYP2C19 genotype guided antiplatelet treatment strategy to the treatment strategy with the newer antiplatelet drugs i.e. ticagrelor and prasugrel in subgroups. To compare the number of patients in whom the antiplatelet drug is prematurely discontinued or switched in both treatment groups. ;Primary end point(s): The primary efficacy endpoint is the number of patients who either died, dev | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints are the number of patients who either died, died from cardiovascular death, from cerebrovascular death, developed recurrent MI, definite stent thrombosis, probable stent thrombosis, possible stent thrombosis, underwent urgent target vessel revascularisation (TVR), hospitalization for ACS, developed stroke or the number op patients with combinations of these endpoints at 30 days and at one year after PCI. Secondary safety endpoints are the number of patients with (non-)CABG-related major bleeding, major bleeding, minor bleeding, life threatening bleeding, fatal bleeding, intracranial bleeding, bleed requiring transfusion or the number of patients with combinations of these endpoints at at one year after PCI. A secondary endpoint is the number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug. ;Timepoint(s) of evaluation of this end point: At 30 days and one year following PCI. | — |
Countries
Netherlands
Contacts
Public ContactJurrien M ten Berg
St. Antonius Hospital
Outcome results
None listed