Coronary atherosclerotic disease, Platelet Aggregation, Cytochrome P-450 Enzyme System
Conditions
Interventions
At the index procedure, a blood sample from the patients will be obtained for DNA isolation. It will be used to identify polymorphisms in genes CYP2C19, PON1 and ABCB1. A sample size of 200 patients w
Genetics
Other
G09.188.124.552.624
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Consecutive patients submitted to percutaneous coronary intervention at the interventional cardiology unit at FMRP-USP. Agreement with the consent form.
Exclusion criteria
Exclusion criteria: Patients submitted only to balloon angioplasty or with contraindication to clopidogrel use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evalauting the percentage of patients carrying genetic polymorphisms in the CYP2C19, PON1 and ABCB1 genes (1), veryfied though the Drug Metabolism Genotyping Assay (2) with a significant difference of at least 5% when compared to gene polymorphisms in other populations (3) Expected outcomes: CYP2C19*2: 75 % normal homozygotes, 20% de heterozigotes e 5% altered homozigotes. ABCB1: 22% normal homozigotes, 50% heterozigotes, 28% altered homozigotes alterado. PON1: 10% normal homozigotes, 50% heterozigotos e 40% altered homozigotes.;Comparison of patient platelet aggregometry (1) through light transmission aggregomety (2) in three time points, with double antiplatelet therapy, with aspirin only, and with clopidogrel only. In the case of aspirin, arachdonic acid is used to stimulate platelets. Aspirin resistance is considered when less than 80% of light is transmitted with 5 minutes of the assay. In the case of clopidogrel, ADP is used to stimulate platelets. Clopidogrel resistance is considered when less than 86% of light is transmitted with 5 minutes of the assay. Expected outcomes: 14.7% of clopidogrel resistance and 5% aspirin resistance. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is a composite of cardiac death, non-fatal myocardial infarction, stroke, new ischemia-guided revascularization and stent thrombosis (1) that will be evaluated through the patient follow-up and by going after the patient or his family if he does not show up at the follow-up visits until the end of the year (2) Expected outcome: we expect 7 to 8% of events in the first year. | — |
Countries
Brazil
Contacts
Public ContactJulio Marchini
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed