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Report for Clinical Trial NCT01990989

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT01990989 Acute Coronary Syndrome
MeSH:Acute Coronary Syndrome

Primary Outcomes

Description: A threshold of 50% maximal post-procedural aggregation was chosen to define HPR.

Measure: high on-treatment platelet reactivity (HPR)

Time: After 30 days maintenance dose of clopidogrel administration

Secondary Outcomes

Description: The composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke , urgent coronal revascularization,and stent thrombosis.

Measure: Composite ischemia cardiovascular outcomes

Time: 1 year

Description: The primary clinical safety end point of the study is the 1-year incidence of combined major and minor bleeding events defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria . TIMI major bleedings include hemoglobin reduction >5 g/dL(with or without obvious bleeding spots) , intracranial hemorrhages, and cardiac tamponade.TIMI minor bleedings include hemoglobin reduction >3 g/dL but ≤5 g/dL ,macroscopic hematuria,hemoptysis,hematemesis,ecchymoma,mucous membrane and other minor bleedings.

Measure: Hemorrhagic complications

Time: 1 year
Time Perspective: Prospective

Cohort

There are 2 SNPs

SNPs

1 rs4244285

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.

2 rs4986893

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.


HPO Nodes