An observational study in Acute Coronary Syndrome, sponsored by October 6 University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by October 6 University · Observational
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.
Background and Rationale
Percutaneous coronary intervention (PCI) is a widely used procedure for the treatment of coronary artery disease. Following PCI, dual antiplatelet therapy (DAPT), typically consisting of aspirin and a P2Y12 receptor inhibitor, is used to reduce thrombotic complications, including myocardial infarction and stent thrombosis. Clopidogrel remains a commonly prescribed P2Y12 inhibitor in patients undergoing PCI.
Clopidogrel is a prodrug that requires metabolic activation to produce its active antiplatelet metabolite. The CYP2C19 enzyme plays a major role in this process. Genetic polymorphisms in CYP2C19 can influence enzyme activity, clopidogrel activation, and the resulting antiplatelet response. The CYP2C192 (rs4244285) and CYP2C193 (rs4986893) alleles are associated with reduced or absent enzyme function, whereas CYP2C19*17 (rs12248560) is associated with increased enzyme expression or activity. The presence of reduced-function alleles may contribute to inadequate platelet inhibition and an increased risk of ischemic events in some patients receiving clopidogrel.
CYP2C19 allele frequencies vary among populations. However, data describing the prevalence of these variants, predicted metabolizer phenotypes, and their potential associations with clinical outcomes in Egyptian patients undergoing PCI remain limited. A multicenter study across Egypt may provide valuable population-specific pharmacogenetic information and help inform future research into genotype-guided antiplatelet therapy.
Study Objectives
Primary Objective
To determine the prevalence of CYP2C192, CYP2C193, and CYP2C19*17 genetic variants among Egyptian adults receiving clopidogrel following PCI.
Secondary Objectives
To characterize CYP2C19 genotype distributions and predicted metabolizer phenotypes among the study participants.
To investigate associations between CYP2C19 genetic variants and participants' demographic characteristics, cardiovascular presentation, comorbidities, and medication use.
To evaluate the potential associations between CYP2C19 genotypes or predicted metabolizer phenotypes and clinical outcomes following PCI, including ischemic events, bleeding, and hospitalization.
To generate multicenter Egyptian data that may inform future pharmacogenetic research and the development of personalized antiplatelet treatment strategies.
Study Design and Setting
This is a prospective, observational, multicenter cohort study involving approximately 1,000 adult Egyptian patients recruited from cardiac catheterization centers across Egypt. Eligible participants will be patients aged 18 years or older undergoing PCI and receiving clopidogrel as part of antiplatelet therapy.
The study will include patients undergoing PCI in the setting of acute coronary syndromes, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina. Other clinical presentations or indications for PCI will be documented as specified in the study protocol and eligibility criteria.
The study will not randomize participants to treatment groups or assign antiplatelet therapy. Clinical management will remain the responsibility of the treating healthcare team.
Study Procedures
After eligibility has been assessed and the applicable consent procedures have been completed, demographic and clinical information will be collected using a standardized data collection form.
Approximately 3 mL of peripheral venous blood will be collected in an EDTA-containing tube for genetic analysis. Each specimen will be labeled with a unique study code to protect participant confidentiality. Samples will be stored at approximately -20°C and transported to the designated molecular laboratory in an appropriate insulated transport container under the study's specimen-handling procedures.
Genomic DNA will be extracted from the blood samples. DNA quality will be assessed before genotyping. TaqMan single-nucleotide polymorphism (SNP) genotyping using real-time polymerase chain reaction (PCR) will be performed to identify the selected CYP2C19 variants.
The genetic analysis will include:
CYP2C19*2 (rs4244285) CYP2C19*3 (rs4986893) CYP2C19*17 (rs12248560)
Genotype results will be used to characterize allele and genotype frequencies and, where supported by the available genotype information and an appropriate standardized classification system, to assign predicted CYP2C19 metabolizer phenotypes.
Data Collection
The following information will be collected where applicable and available.
Demographic and Anthropometric Characteristics
Age Sex Height and weight Smoking status
Cardiovascular Presentation and PCI Characteristics
Clinical presentation, including STEMI, NSTEMI, unstable angina, and other documented coronary syndromes Indication for PCI Acute coronary syndrome or chronic coronary syndrome status, as applicable Stent implantation and relevant procedural characteristics
Medical History and Comorbidities
Diabetes mellitus Hypertension Dyslipidemia Previous myocardial infarction Previous PCI Previous coronary artery bypass grafting (CABG) Other previous coronary revascularization Heart failure Stroke or transient ischemic attack (TIA) Peripheral vascular disease Chronic kidney disease Chronic liver disease Atrial fibrillation History of gastrointestinal or intracranial hemorrhage Active cancer
Medication data will include the use of aspirin, statins, beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), and oral anticoagulants. Other clinically relevant medications may be recorded according to the study protocol.
Clinical Outcomes
Clinical outcomes occurring after PCI will be recorded according to the study's prespecified definitions and follow-up procedures. The outcomes of interest include the following categories.
Ischemic and Cardiovascular Outcomes
Major adverse cardiovascular events (MACE), according to the study's prespecified definition Cardiovascular death All-cause mortality Myocardial infarction Stent thrombosis, including definite or probable stent thrombosis where ascertainable Target-vessel revascularization Target-lesion revascularization Repeat PCI CABG Stroke or TIA Recurrent angina
Bleeding Outcomes
Major bleeding Minor bleeding
Bleeding events will be classified according to the definitions specified in the study protocol.
Hospitalization for heart failure Hospitalization for recurrent acute coronary syndrome Bleeding-related hospitalization Other cardiovascular-related hospitalization
The ascertainment and classification of clinical outcomes will follow the available clinical documentation and the study's predefined outcome criteria.
Genetic and Statistical Analysis
Allele and genotype frequencies will be calculated for CYP2C19*2, CYP2C19*3, and CYP2C19*17. Predicted metabolizer phenotype distributions will be described using an appropriate standardized genotype-to-phenotype translation framework.
Descriptive statistical methods will summarize demographic characteristics, clinical presentation, comorbidities, medication use, genetic findings, and clinical outcomes. Associations between genetic variants or predicted metabolizer phenotypes and participant characteristics will be evaluated using appropriate statistical tests.
Where the number of observed events and the available data permit, regression or other suitable multivariable analyses will be used to investigate associations between CYP2C19 genetic findings and clinical outcomes. Potential confounding factors will be considered in the analysis. Effect estimates will be reported with appropriate measures of uncertainty, such as confidence intervals, where applicable.
The analysis will account for the observational nature of the study. Associations will not be interpreted as proof that a genetic variant directly causes a clinical outcome. The adequacy of the data for individual outcome analyses will depend on the number of observed events and the completeness of follow-up.
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →October 6 University is the lead sponsor of 142 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of approximately 1,000 Egyptian adults aged 18 years or older undergoing percutaneous coronary intervention (PCI) for coronary artery disease at multiple cardiac catheterization centers across Egypt. Participants will include patients presenting with ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina who receive clopidogrel as part of antiplatelet therapy following PCI. Demographic and clinical characteristics, medical history, concomitant medications, and post-PCI clinical outcomes will be collected prospectively. Peripheral blood samples will be obtained for CYP2C19 genotyping to determine the prevalence of the *2, *3, and *17 variants and investigate their associations with major adverse cardiovascular events and bleeding outcomes.
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Exclusion Criteria:
Approximately 1,000 Egyptian adults aged 18 years or older undergoing percutaneous coronary intervention (PCI) and receiving clopidogrel as part of antiplatelet therapy will be enrolled from multiple cardiac catheterization centers across Egypt. Eligible patients may present with STEMI, NSTEMI, or unstable angina, according to the study eligibility criteria. Demographic information, medical history, cardiovascular characteristics, concomitant medications, and clinical outcomes will be collected prospectively. Approximately 3 mL of peripheral blood will be collected for DNA extraction and genotyping of CYP2C19\*2 (rs4244285), CYP2C19\*3 (rs4986893), and CYP2C19\*17 (rs12248560) using TaqMan real-time PCR. This is an observational study; no study-assigned intervention will be administered, and antiplatelet treatment will be determined by the treating healthcare team.
Drug: Clopidogrel
Clopidogrel is an antiplatelet medication prescribed as part of routine clinical care following PCI. Its use, along with other clinical characteristics and outcomes, will be documented. The study does not assign clopidogrel treatment or determine its dose.
Also known as: Plavix
Prevalence of CYP2C19*2, CYP2C19*3, and CYP2C19*17 Genetic Variants
The proportion of participants carrying each of the CYP2C19\*2 (rs4244285), CYP2C19\*3 (rs4986893), and CYP2C19\*17 (rs12248560) variants will be determined using TaqMan real-time PCR genotyping. Allele frequencies and genotype distributions will be calculated among Egyptian patients receiving clopidogrel following PCI.
Time frame: At enrollment, using peripheral blood samples collected during the study.
Association Between CYP2C19 Genetic Variants and Major Adverse Cardiovascular Events (MACE)
Evaluate the association between CYP2C192, CYP2C193, and CYP2C19\*17 genotypes or predicted metabolizer phenotypes and the occurrence of major adverse cardiovascular events following PCI, according to the study's prespecified MACE definition.
Time frame: 6-months follow up after PCI
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 7 months after the start.
Of 237 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 7 months is below that.
Counting every sponsor, half of 274 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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