chronic coronary syndrome coronary artery desisease stable coronary artery disease
Conditions
Interventions
All patients will be randomized and will undergo CYP2C19 genotyping using a
pharyngeal swab and/or a blood sample.
After CYP2C19 genotyping, patients will be divided into two groups:
Group 1: P2Y12
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Patients >= 18 years of age • Patients with CCS undergoing successful elective PCI • Patients with written informed consent as approved by the ethics committee
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Contraindication to aspirin • Contraindication to prasugrel, ticagrelor or clopidogrel • Under the age of 18 years • Planned cardiac valve surgery • Need for chronic oral anticoagulation • PCI when admitted for ACS • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • The primary safety endpoint is the incidence of minor, moderate or severe bleeding (Bleeding Academic Research Consortium 2, 3 and 5) • Primary efficacy endpoint is the incidence of a composite of cardiovascular mortality, myocardial infarction, stent thrombosis and stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Individual components and combinations of the primary and secondary end points. • To evaluate the net clinical benefit (a composite of all-cause death, MI, stroke and major bleeding defined as BARC type 3 or 5 bleeding at 12 months) • Angina frequency and stability, physical limitations, treatment satisfaction and quality-of-life measured by SF-12 and SAQ • Direct and indirect costs defined as: costs of medication, bleeding events needing medical intervention, re-admission due to bleeding or thrombotic event, prolonged admission time due to ischemic or bleeding events, costs of genotyping | — |
Countries
Netherlands
Outcome results
None listed