Kosteneffectiviteit van een op het CYP2C19 genotype gebaseerde behandeling met plaatjesremmende geneesmiddelen bij patiënten met een hartinfarct die gedotterd zijn.

Recruiting

Conditions: Myocardial infarction, Pharmacogenetics, antiplatelet drugs, cost-effectiveness, PCI

Lead Sponsor: St. Antonius HospitalKoekoekslaan 13435 CM NieuwegeinThe Netherlands

Recruitment & Eligibility

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

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 investigators' opinion;

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the number of patients who either died, developed a recurrent myocardial infarction (MI), underwent urgent target vessel revascularisation (TVR), developed definite stent thrombosis or stroke at 30 days and at one year after PCI.<br><br /><br /><br>The primary safety endpoint is the number of patients with non-CABG-related major bleeding at one year after PCI.<br><br /><br /><br>The primary endpoints in terms of pharmacoeconomics are quality of life, direct medical costs e.g. costs for blood transfusions, drugs, hospitalization and non-medical costs e.g. costs incurred due to sickness absence.

Secondary Outcome Measures

Name	Time	Method
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), developed stroke or the number op patients with combinations of these endpoints at 30 days and at one year after PCI.<br><br /><br /><br>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.<br><br /><br /><br>A secondary endpoint is the number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug.<br><br /><br /><br>A tertiary study parameter is the number of patients with CYP2C19 and other genetic variants.