N/A
N=283
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
Coronary Artery Disease · Clopidogrel Resistance · Coronary Thrombosis · Adverse Cardiac Events · Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT06665919 ↗Enrolled (actual)
283
Serious AEs
23.2%
Results posted
Sep 2025
Primary outcome: Primary: Number of Study Participants Who Died From Any Cause (Death From Any Cause) — 8; 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CYP2C19 Genotype-Guided Clopidogrel Treatment (Other); CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel (Other); The Conventional Clopidogrel Treatment (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Vistamedi Ltd.
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Participants Who Died From Any Cause (Death From Any Cause) |
8; 2; 7 | — |
| PRIMARY Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) |
5; 1; 6 | — |
| PRIMARY Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) |
3; 1; 1 | — |
| SECONDARY Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) |
4; 1; 4 | — |
| SECONDARY Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) |
14; 3; 16 | — |
| SECONDARY Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) |
5; 1; 3 | — |
| SECONDARY Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) |
3; 2; 4 | — |
| SECONDARY Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) |
2; 4; 4 | — |
| SECONDARY Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) |
14; 4; 9 | — |
| SECONDARY Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) |
17; 4; 16 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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;
Exclusion Criteria
- Concomitant using of potent CYP3A4 or CYP2C19 inhibitors;
- Morbid obesity, BMI 40 kg/sq.m or more;
- Type 1 diabetes mellitus;
- Poorly controlled type 2 diabetes mellitus, HbA1c - 9% or more;
- Acute Myocardium Infarction;
- Coronary artery bypass grafting performed within the last 12 weeks;
- 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;
- Clinically important leucopenia, lymphopenia, thrombocytopenia or thrombocytosis;
- 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;
- Blood transfusion during the past 6 months or its refusal;
- 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;
- Current chemotherapy or immunosuppressive therapy;
- Ongoing immunosuppression or immunosuppressive conditions;
- Pregnancy or lactation period;
- Any disease/condition control of which is not achieved;
- Personal (patient/physician dependent) or health care system-related circumstances that can restrict or limit any study procedures or operations.
Data sourced from ClinicalTrials.gov (NCT06665919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.