NCT06759272Not yet recruitingPhase 4
Impact of CYP2C19 Genotype-guided Approach in Antiplatelet Therapy on Platelet Reactivity Index Among Coronary Artery Disease (CAD) Patients
Pharmacogenomic Markers of Clopidogrel Resistance in Malaysian CAD Patients: Clinical Efficacy and Economic Evaluation of CYP2C19 Genotype-Guided Therapy
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 29 Dec 2024
- Start date
- Feb 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Nur Hafizah Annezah binti Utuh
- Diseases
- Coronary artery disease
- NCT number
- NCT06759272
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From Feb 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Pakar Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.