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NOT YET RECRUITING

NCT06759272

PHASE4

Impact of CYP2C19 Genotype-guided Approach in Antiplatelet Therapy on Platelet Reactivity Index Among Coronary Artery Disease (CAD) Patients

Sponsor: Nur Hafizah Annezah binti Utuh

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the pilot intervention of CYP2C19 genotype-guided antiplatelet therapy works to reduce the occurrence of cardiovascular events after Percutaneous Coronary Intervention (PCI) done in coronary artery disease patients. It will also learn about the comparison between clopidogrel and ticagrelor. The main questions it aims to answer are: To compare the impact of CYP2C19 genotype-guided antiplatelet therapy, universal use of clopidogrel and ticagrelor treatment on platelet reactivity. To compare the impact of CYP2C19 genotype-guided antiplatelet therapy, universal use of clopidogrel and ticagrelor treatment on the risk of major adverse cardiovascular events (MACE) among newly recruited stable CAD patients. Participants will: Take drug clopidogrel or ticagrelor, based on the random group allocation every day for 1 month. One group of patients will undergone CYP2C19 genetic test for genotype-guided antiplatelet therapy, whether clopidogrel or ticagrelor. Visit the clinic post 30 days of PCI for follow-ups and platelet function tests.

Official title: Pharmacogenomic Markers of Clopidogrel Resistance in Malaysian CAD Patients: Clinical Efficacy and Economic Evaluation of CYP2C19 Genotype-Guided Therapy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-02

Completion Date

2026-02

Last Updated

2025-01-07

Healthy Volunteers

Conditions

Coronary Arterial Disease (CAD)ACS (Acute Coronary Syndrome)SCAD

Interventions

GENETIC

CYP2C19 genotype-guided antiplatelet therapy

A panel of genes including CYP2C19\*2 (rs4244285) and CYP2C19\*3 (rs4986893) will be genotyped using the real-time PCR and the expected turnover time will be 48 hours. Patients who are identified to have reduced function CYP2C19 allele will receive 90 mg ticagrelor and patients with wild-type CYP2C19 allele will receive clopidogrel 75 mg in the next scheduled dose. The switching done from clopidogrel to ticagrelor is supported by Antiplatelet Therapy Switching Clinician Guideline, whereby in the maintenance or low risk phase, there is generally no need to administer a loading dose of ticagrelor; one can switch directly to ticagrelor maintenance dose 24 hours after the last dose of clopidogrel

Inclusion Criteria: * Males or females * Aged between 18 to 80 years old * Patients presents with stable CAD or acute coronary syndrome (ACS) * Eligible for percutaneous coronary intervention (PCI) * Willing to provide DNA sample via blood drawn for genotyping and platelet reactivity assessment * Willing and able to provide informed written consent Exclusion Criteria: * Primary PCI or rescue PCI * Any urgent/emergent coronary angiography procedure that would not allow for genetic testing to be performed before PCI * Failure of index PCI * Patient or physician refusal to enroll in the study * Patient with known CYP2C19 genotype prior to randomization * Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure * Anticipated discontinuation of clopidogrel or ticagrelor within the 12 months follow up period (e.g. for elective surgery) * History of ischaemic or haemorrhagic stroke * History of allergies to aspirin, ticagrelor, or clopidogrel * Suffering from HIV or any blood transmitted disease. * Considered at high risk of bleeding\* * Stage 5 chronic kidney disease (CKD) based on the National Kidney Foundation, Kidney disease quality outcome initiative (KDQOI) definition (Levey et al., 2005), or those who were on haemodialysis * Pre-existing liver cirrhosis * Pregnant women at any stage of gestation * Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematous, etc.) * Patient is receiving chronic anticoagulation therapy (i.e. vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor) * Concomitant use of simvastatin/lovastatin \>40 mg qd * Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine) * Non-cardiac condition limiting life expectancy to less than a year, per judgement of physician

Locations (1)

Hospital Pakar Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia