Clinical Research Directory

Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI

Sponsor: October 6 University

Summary

Coronary artery disease occurs when the blood vessels supplying the heart become narrowed or blocked. Percutaneous coronary intervention (PCI) is a procedure used to restore blood flow to the heart, often by inserting a stent. After PCI, patients are commonly treated with dual antiplatelet therapy, which usually includes aspirin and a second medicine, such as clopidogrel, to reduce the risk of blood clots. Clopidogrel must be converted by the body into its active form before it can work effectively. An enzyme called CYP2C19 plays an important role in this process. Genetic differences in the CYP2C19 gene can affect how well clopidogrel is activated. Some genetic variations, including CYP2C192 and CYP2C193, are associated with reduced enzyme activity, while CYP2C19\*17 is associated with increased enzyme activity. These differences may influence a patient's response to clopidogrel and could be related to cardiovascular events or bleeding after PCI. There is limited information about the frequency of these genetic variations and their relationship with clinical outcomes among Egyptian patients receiving clopidogrel after PCI. The purpose of this study is to determine the prevalence of CYP2C192, CYP2C193, and CYP2C19\*17 genetic variations in Egyptian patients undergoing PCI and receiving clopidogrel. The study will also examine the distribution of CYP2C19 genotypes and predicted metabolizer groups, their relationship with patient characteristics, and their potential association with cardiovascular events, bleeding, and hospitalizations after PCI. Approximately 1,000 adult Egyptian patients will be recruited from multiple cardiac catheterization centers across Egypt. Information about participants' demographic characteristics, medical history, cardiovascular condition, and medications will be collected. A small blood sample (approximately 3 mL) will be obtained for DNA extraction and genetic testing using a laboratory method called TaqMan real-time polymerase chain reaction (PCR). Participants' clinical outcomes will be assessed according to the study protocol, including cardiovascular events, heart attack, stent thrombosis, repeat coronary procedures, stroke, bleeding, and cardiovascular-related hospitalizations. This is a prospective observational study. Participants will receive their clinical care according to the decisions of their treating healthcare professionals. The study will observe the relationship between genetic variations and clinical outcomes; it will not assign treatments based on genetic results. The findings may improve understanding of CYP2C19 genetic variation in the Egyptian population and provide evidence to support future research on personalized antiplatelet treatment after PCI.

Official title: Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel (Plavix®) Following Percutaneous Coronary Intervention: A Prospective Multicenter Cohort Study

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