Acute Coronary Syndrome Clinical Trial
Official title:
Clopidogrel Pharmacogenetic Score System Established for Chinese Patients
The aim of the present study is to evaluate candidate variables,including Cytochrome P450 2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score that can be easily adopted by clinicians to identify patients who are at risk for HPR and composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet therapy.
There is a large inter-individual variability of biological antiplatelet responsiveness in
patients treated with clopidogrel. Our previous study suggested that in clopidogrel treated
Chinese patients with acute coronary syndromes(ACS),carriers of at least one CYP2C19
loss-of-function allele could predict greater risk of high on-treatment platelet reactivity
(HPR), with the impact mainly attributing to CYP2C19*2. But as we know, CYP2C19*2 could only
explain a small proportion of the variability. Various clinical and demographic variables
have been considered to influence response to antiplatelet therapy.
Study objectives:
The present study aims to evaluate candidate variables,including CYP2C19 gene polymorphisms,
clinical and demographic variables,to establish a simple risk score to identify patients who
are at risk for HPR and composite cardiovascular outcomes .
Study design:
Step 1: Population enrollment and medication This mono-center study will be conducted in
General Hospital of Chinese People's Liberation Army. Consecutive patients more than 18
years old admitted for ACS will be recruited after giving informed consents. After
admission, all enrolled patients will be treated with 100 mg aspirin and 75mg clopidogrel
per day. A loading dose of 300 mg clopidogrel will be given to patients undergoing coronary
angiography.
Step 2: Clinical and demographic data collection A detailed demographic and medical data
will be extracted from medical charts and prescription records. For the development of the
risk score system, we will chose variables that are available in routine clinical practice.
Clinical candidate variables include smoking history, diabetes,hypertension, renal failure
with a serum creatinine>1.5mg/dL-1, hypercholesterolemia, left ventricular dysfunction, age,
gender, acute coronary syndrome on admission and co-medication with statins, calcium channel
inhibitor, and proton pump inhibitors.
Step 3 : Platelet function measurements and Genotyping After 5 days maintenance dose of
clopidogrel administration, blood samples will be drawn for light transmittance aggregometry
(LTA) testing, using an APACT-4 aggregometer (LABiTec, Germany). The magnitude of
on-treatment platelet reactivity was quantified using LTA with 20µmol/L ADP(adenosine
disphosphate) as the agonist. Aggregation was expressed as the maximal percentage change in
light transmittance from baseline, with platelet-poor plasma as the reference.
Genomic DNA will be extracted from the peripheral blood leucocytes of each patient. The loss
of function alleles, CYP2C19*2 (rs4244285) and CYP2C19*3 (rs4986893), will be genotyped by
the polymerase chain reaction(PCR)-ligase detection reactions(LDR)sequencing method.
Step 4: Follow-up At one year, the incidence of composite cardiovascular outcomes will be
assessed by review of the patients'charts on re-admission or by telephone interview.
Telephone interviewers are blinded with respect to the results of platelet aggregation and
genotypes.
Step 5: Statistical analysis and development of risk score Logistic regression and Cox
proportional hazards survival regression will be used to develop the risk score system with
the candidate variables including clinical and demographic variables, CYP2C19 genotypes, and
platelet aggregation.
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Observational Model: Cohort, Time Perspective: Prospective
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