NCT06665919Completed
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug metabolism. The study aimed to answer two research questions: * Does CYP2C19 genotype-guided clopidogrel treatment provide better clinical outcomes when compared with conventional treatment selection led without CYP2C19 genotyping? * Can CYP2C19 genotype-guided antiplatelet treatment be beneficially applied in real-world clinical practice? After obtaining the informed consent eligible study participants screened by inclusion and exclusion criteria were randomized and allocated into two groups: * for whom the CYP2C19 genotype-guided clopidogrel treatment has been applied - the experimental group, * for whom conventional clopidogrel has been applied without CYP2C19 genotyping - the control group. The experimental group participants underwent CYP2C19 genotyping. Study participants with CYP2C19 normal function alleles (NFA) \*2, \*3 genotypes constituted the separate experimental arm and received clopidogrel-based preventive antiplatelet treatment. Participants with CYP2C19 \*2 and \*3 loss of function (LoF) alleles were allocated to the separate experimental group and received preventive antiplatelet treatment alternative to clopidogrel. Study participants who had not undergone CYP2C19 genotyping and received conventional preventive antiplatelet treatment with clopidogrel were assigned as active comparators. All participants in the experimental and comparator groups underwent standard clinical investigations by current guideline recommendations for: * the initial assessment, * follow-up and detection of major adverse cardiovascular events. All patients received the conventional drug treatment by current guideline recommendations for chronic coronary artery disease and comorbid condition management and adverse cardiovascular events prevention. The main research outcome measures include: * evaluating clinical outcomes of CYP2C19 genotype-guided antiplatelet treatment application, * describing models for application of CYP2C19 genotype-guided antiplatelet treatment, * learning about potential access points to the real practice process pipeline for implementation of genotype-guided medication treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 283 (actual)
- First submitted
- 29 Sept 2024
- Start date
- 15 Jun 2023
- Primary completion date
- 15 May 2025
- Lead sponsor
- Vistamedi Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06665919
What you commit to
- Study type: Interventional
- Participants enrolled: 283
- From 15 Jun 2023 to the primary completion date, 15 May 2025
- 4 sites 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
- Concomitant using of potent CYP3A4 or CYP2C19 inhibitors;
- Current chemotherapy or immunosuppressive therapy;
Other illness
- Type 1 diabetes mellitus;
- Valvular heart disease due to dysplasia, connective tissue disorders or inflammatory disorders, or valvular disorders requiring cardiac surgery;
- History of severe hepatic impairment;
- Severe chronic kidney disease;
- History of hemorrhagic diathesis or coagulopathy;
- An active or an obvious threat of bleeding (including GI bleeding):
- Bleeding within the past 6 months that required hospitalization;
- History of intracranial hemorrhage;
- Cardiac or non-cardiac degenerative disease, including: cardiomyopathy, restrictive lung disease, or Neurodegenerative diseases;
- Malignant tumor (cancer) that limits life expectancy to less than one year;
- Ongoing immunosuppression or immunosuppressive conditions;
- Any disease/condition control of which is not achieved;
Lab values
- Poorly controlled type 2 diabetes mellitus, HbA1c - 9% or more;
Other
- Morbid obesity, BMI 40 kg/sq.m or more;
- Acute Myocardium Infarction;
- Coronary artery bypass grafting performed within the last 12 weeks;
- Clinically important leucopenia, lymphopenia, thrombocytopenia or thrombocytosis;
- Blood transfusion during the past 6 months or its refusal;
- Pregnancy or lactation period;
- Personal (patient/physician dependent) or health care system-related circumstances that can restrict or limit any study procedures or operations.
Who the study is looking for
- Diagnosed with chronic coronary artery disease;
- Undergone elective PCI within the last 12 weeks without procedure-related complications;
- LVEF≥38% after index PCI;
- Completed informed consent form for participation in the study;
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tbilisi Institute of Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| T. Oragvelidze Cardiology Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| 1st University Clinic of the Tbilisi State Medical University Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Cardio Expert Ltd., Clinic Cardio Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.