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

Launched by NUR HAFIZAH ANNEZAH BINTI UTUH · Dec 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a personalized approach to antiplatelet therapy, based on a genetic test called CYP2C19 genotype testing, affects patients with coronary artery disease (CAD) after they undergo a procedure called Percutaneous Coronary Intervention (PCI). The goal is to see if this personalized method can reduce the risk of serious heart events and how it compares to standard treatments using two medications, clopidogrel and ticagrelor. Participants will be randomly assigned to take either clopidogrel or ticagrelor daily for one month and will have follow-up visits to check their platelet function.

To participate in this trial, you need to be between 18 and 80 years old, have stable CAD or acute coronary syndrome, and be eligible for PCI. You must also be willing to provide a blood sample for genetic testing. However, certain conditions, like a history of stroke, severe kidney disease, or being pregnant, would exclude you from participating. If you join the study, you'll receive close monitoring and care to ensure your safety and well-being throughout the trial.

Gender

ALL

Eligibility criteria

• 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