Testing gene-guided blood thinner choice after heart stent procedures
Tests choosing a blood thinner by gene type in adults with heart artery disease.
Plain-language title generated from the registry record
Registry title: Impact of CYP2C19 Genotype-guided Approach in Antiplatelet Therapy on Platelet Reactivity Index Among Coronary Artery Disease (CAD) Patients
Key facts
- Where
- Kota Bharu, MalaysiaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06759272, who can take part
Where in Malaysia
- Hospital Pakar Universiti Sains MalaysiaKota Bharu, MalaysiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nur Hafizah Annezah binti Utuh
- Trial code
- NCT06759272
- Record updated
- 7 January 2025
- Original description
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.Read full original descriptionShow less
Pharmacogenomic Markers of Clopidogrel Resistance in Malaysian CAD Patients: Clinical Efficacy and Economic Evaluation of CYP2C19 Genotype-Guided Therapy
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.
Inclusion: 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: Patient with known CYP2C19 genotype prior to randomization; Anticipated discontinuation of clopidogrel or ticagrelor within the 12 months follow up period (e.g. for elective surgery); 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); Failure of index PCI; 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; Non-cardiac condition limiting life expectancy to less than a year, per judgement of physician; Primary PCI or rescue PCI; Any urgent/emergent coronary angiography procedure that would not allow for genetic testing to be performed before PCI; Patient or physician refusal to enroll in the study; Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure; Pre-existing liver cirrhosis; Pregnant women at any stage of gestation.