Impact of CYP2C19 Genotype-guided Approach in Antiplatelet Therapy on Platelet Reactivity Index A… (NCT06759272) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Impact of CYP2C19 Genotype-guided Approach in Antiplatelet Therapy on Platelet Reactivity Index Among Coronary Artery Disease (CAD) Patients
Malaysia120 participantsStarted 2025-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major adverse cardiovascular events (MACE)
Timeframe: From enrollment to 30 days post PCI
Trial details
NCT IDNCT06759272
SponsorNur Hafizah Annezah binti Utuh
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-02
Contact for this trial
Nur Hafizah Annezah Utuh, Doctor of Philosophy (PhD)