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.
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)
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
Parallel
CYP2C19 genotype-guided antiplatelet therapy
GeneticA 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
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) is defined as the composite of all-cause mortality, recurrent myocardial infarction (MI), repeat revascularization and stroke. The fourth universal definition of MI was used to retrospectively analyse recurrent MI. Any revascularization of the target coronary artery following the index incident, whether percutaneous or surgical, was referred to as repeat revascularization.
Platelet Reactivity Index (PRI)
Based on the PRI assessment, the participants can be categorised into treatment responders and non-responders. Clopidogrel and ticagrelor non-responses will be reported based on the cut-off point of PRI≥50%. For VASP method, a platelet reactivity index (PRI) of \> 50% was defined as high on-treatment platelet reactivity (HTPR) which could lead to higher risk of ischaemic events post PCI, and a PRI of \< 16% was defined as low on-treatment platelet reactivity (LTPR) which could lead to higher risk of bleeding. Hence, the optimal therapeutic window for antiplatelet therapy according to this VASP method is 17-49%
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Nur Hafizah Annezah binti Utuh
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
