CLOPIDOGREL, POOR METABOLISM of (Disorder) Clinical Trial
Official title:
Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients
Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering from Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel varies substantially among individuals. Several loss‐of‐function polymorphisms have been identified that may influence clinical outcome in patients presenting with acute coronary syndromes (ACS) who are treated with clopidogrel. However their contribution to high on-treatment platelet reactivity (HPR) in clopidogrel treated Chinese patients is less known. As far as we know, ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention trial. we will conduct an interventional study to compare the antiplatelet efficiency between clopidogrel and ticagrelor by the guidance of CYP450 2C19*2 (CYP2C19*2) , using Taqman genotyping method.
Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering
from Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel
varies substantially among individuals. Several loss-of-function polymorphisms have been
identified that may influence clinical outcome in patients presenting with acute coronary
syndromes (ACS) who are treated with clopidogrel.
Mounting evidence suggests a crucial role for the loss-of-function CYP2C19*2 genetic
variant. Carriers of CYP2C19*2 allele were at 30% higher risk for major adverse clinical
events compared to non-carriers. CYP2C19*2 alone was also associated with increased
mortality and stent thrombosis. These findings led the American Food and Drug Administration
to issue a boxed warning for clopidogrel stating that poor metabolizers may not receive the
full benefit of the drug. Thus, routine genotyping in the context of dual anti-platelet
therapy is necessary.
Individual dual anti-platelet treatment is feasible to give the presence of treatment
alternatives such as ticagrelor that is not dependent on gene-based metabolic activation and
demonstrated greater clinical efficacy than clopidogrel. Individualized administration of
ticagrelor may have the potential to successfully minimize adverse ischemic events.
200 patients undergoing percutaneous coronary intervention (PCI) for treatment of
non-ST-elevation acute coronary syndrome or stable coronary artery disease will be eligible
for enrollment. Patients will be randomly assigned to a strategy of genotyping(using Taqman
genotyping method) or standard treatment . CYP2C19*2 carriers will be given 90 mg ticagrelor
twice daily, and non-carriers and patients in the standard treatment group will be given 75
mg clopidogrel daily. At the end of the 5 day antiplatelet treatment, efficacy of the
treatment strategies will be evaluated using light transmittance aggregometry (LTA) method.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02707445 -
Genotyping Influences Outcome of Coronary Artery Stenting
|
N/A |