Coronary Artery DiseaseNCT06665919
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
A study testing CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel and The Conventional Clopidogrel Treatment in people with Coronary Artery Disease and Clopidogrel Resistance, run by Vistamedi Ltd. at 4 sites in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis
- What is being tested?
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel and The Conventional Clopidogrel Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 4 sitesGeorgia
- Study dates
- 15 Jun 2023to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
Georgia4 sites
1st University Clinic of the Tbilisi State Medical University
Tbilisi
Cardio Expert Ltd., Clinic Cardio
Tbilisi
T. Oragvelidze Cardiology Center
Tbilisi
Tbilisi Institute of Medicine
Tbilisi
About this study
Official title: Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI
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:
Read more
- 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.
Read the detailed description
The concept of the study is based on current evidence from multiple genetic and clinical studies. At this stage of development preventive treatment of chronic coronary artery disease after ePCI is challenged by risks related to multi-morbidity, recurrent MACCEs and bleeding. Scientific evidence broadly supports pharmacogenetic approaches for routine use of P2Y12 inhibitors (clopidogrel or alternative). Clopidogrel remains the most commonly used P2Y12 inhibitor in the post-ePCI settings. Along with disease-related and co-morbid factors treatment effects are influenced by the variability of the CYP2C19 genotype in the population, which significantly increases the risk of MACCE in loss of function allele (LoF) carriers even with conventional clopidogrel treatment. To improve treatment, a pharmacogenetic expediency model for drug selection is introduced. CYP2C19 allele genotype-guided clopidogrel or an alternative P2Y12 inhibitor treatment is based on robust evidence.
The study aimed to learn the comparative benefits of CYP2C19 genotype-guided versus conventional clopidogrel treatment selection applied in real clinical practice for preventing adverse cardiovascular events after ePCI in chronic coronary artery disease.
For this purpose, the randomized parallel-group controlled study for CYP2C19 genotype-guided clopidogrel treatment outcomes evaluation for chronic coronary artery disease after the ePCI in real-world practice was conducted.
The study addressed research-specific objectives:
- forming and random allocating of participants into study arms for CYP2C19 allele genotype-guided versus conventional clopidogrel treatment,
- ensuring RT-PCR based assay for CYP2C19 *2, *3 LoF alleles detection in randomly selected study participants and forming the experimental study groups,
- characterizing clinical traits of study participants and observing adverse clinical events during the 12-month course of study intervention treatment;
- evaluating the clinical and non-clinical study outcomes. Following the completion of the informed consent, 283 patients eligible for inclusion and exclusion criteria have been enrolled in the study and randomly allocated into two groups. 83 participants created the control group. They did not undergo CYP2C19 genotyping and received conventional antiplatelet treatment based on clopidogrel. 200 participants were tested for CYP2C19 *2, *3 allele genotype. 157 of those who revealed normal CYP2C19 *2, *3 allele genotype received conventional preventive antiplatelet treatment based on clopidogrel and created a separate experimental arm. 43 participants who revealed CYP2C19 *2, *3 LoF allele genotype required preventive antiplatelet treatment alternative to clopidogrel - based on ticagrelor or prasugrel were allocated into another separate experimental arm and assigned as the perspective arm for further study.
Before inclusion, informed consent was obtained from all study participants (or their legal representatives).
The randomization and study arm allocation processes were blinded for participants, healthcare teams providing medical care and study outcomes assessors. Nevertheless, after randomization and genetic testing, CYP2C19 allele genotyping results were disclosed to the medical care team and study participants to make ongoing clinical management safe and transparent but remained blinded for study outcomes assessors.
RT-PCR-based laboratory assay for CYP2C19 *2, *3 alleles genotyping was carried out only once after randomization for each study participant allocated into the experimental group. Tests were performed in the diagnostic laboratory of Vistamedi Ltd served as the central study laboratory.
The laboratory test report was provided to the authenticated investigator and as well as participant and entered in the study data report form.
Regular healthcare teams conducted clinical management of study participants in a real practice environment including medication treatment under conventional guideline recommendations were detected and initially reported major adverse cardiovascular outcomes, other adverse events, or additional clinical conditions diagnosed or study-related circumstances emerged through the study follow-up period up to the end of the study. Study participants (or their legal representatives) were also allowed to report adverse clinical outcomes, events or emerging circumstances.
For a study participant, the expected end of the study is defined as the end date of the 12-month follow-up from the date of the index ePCI. However, in the case of the clinical endpoint which corresponded to and defined the study outcome measure, the date of such endpoint event was determined as the end of the study, even if earlier than 12 months from the index ePCI.
The study participant could terminate participation by his or her independent decision, from any time of the research and for any reason, which could or could not be established.
Early withdrawal of a participant from the study was considered reasonable if there was repeated non-adherence to the treatment of study interest, rather than sporadic, or when there was preferred to terminate treatment based on the justified best interests of the participant.
Clinical outcomes conventionally defined by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the US Food and Drug Administration (FDA), the Academic Research Consortium for High Bleeding Risk (ARC-HBR) and WHO have been measured by clinical endpoints developed over the course of clinical cases.
Certain elements of the Coronary Revascularization Outcome Questionnaire (CROQ) and Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure profile were used for measuring of Patient-Reported Outcomes (PROs).
Study results were also analyzed using other non-clinical outcome measures that characterized the effectiveness of СYP2C19 genotype-guided P2Y12 inhibitor treatment utilization in real practice.
Data from each study participant were entered into a CRF, the form of which was the same for all participants and study centers.
Study data are collected, stored, and processed into a custom-designed electronic database. Identifiers, study variables and record data are validated with codes to ensure personal data protection.
Personal data, code keys and definitions, and research data are warehoused in separate databases. Only authenticated researchers have access to them. Research data collection centers do not have an internet connection or any other access to the database files.
Study data processing is only allowed by the study procedures given in the study protocol.
After the data collection, the database containing the personal data of the study participants will be deleted.
The de-identified electronic database will be stored after the end of the study for further research purposes for an indefinite period.
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events, Bleeding, Hospitalisations
- Being tested
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
- Keywords
- CYP2C19 Genotype-guided antiplatelet treatment, Clopidogrel Resistance, Double Antiplatelet Treatment, Chronic Coronary Artery Disease, Implementation of Genotype-guided Medication Treatment, Outcome Study
- Medical subject headings
- Coronary Artery Disease, Coronary Thrombosis, Cardiovascular Diseases, Hemorrhage, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 Genotype-Guided Clopidogrel TreatmentOther
Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or an antiplatelet drug (clopidogrel) combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel).
CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to ClopidogrelOther
An antiplatelet drug alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor, or prasugrel).
The Conventional Clopidogrel TreatmentOther
Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or clopidogrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel).
| Study group | Role | What they receive |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Experimental | 157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. Receives: Other: CYP2C19 Genotype-Guided Clopidogrel Treatment |
| Passive Metabolizers of Clopidogrel | Experimental | 43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF *2, *3 alleles carriers. Receives: Other: CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel |
| Unspecified Metabolizers of Clopidogrel | Active comparator | 83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. Receives: Other: The Conventional Clopidogrel Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants Who Died From Any Cause (Death From Any Cause)
The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause)
The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause)
The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Secondary outcomes (7)
Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction)
The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction as recommended by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina)
The clinical event corresponding to the unstable angina, or angina that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA)
The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions for Stroke and Transient Ischemic Attack during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Major Bleeding (Major Bleeding)
The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 3, 5 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding)
The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 1 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event)
The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization)
The clinical event of any repeated coronary revascularization: percutaneous coronary intervention or coronary artery bypass-grafting detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Measured: within a 12-month of the study follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Jun 2023
- Primary completion15 May 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate CYP2C19 allele genotype-guided clopidogrel treatment outcomes after the ePCI study participants were randomly allocated into parallel study arms. Experimental arm participants have undergone CYP2C19 genotyping. Carriers of normal \*2, \*3 alleles - "normal metabolizers" phenotype separated as the experimental arm and participants randomly allocated in the comparators arm without CYP2C19 genotyping - the "unspecified metabolizers" phenotype, have been intervened with clopidogrel-based preventive antiplatelet treatment. Carriers of LoF \*2, \*3 alleles - the "poor metabolizers" phenotype, have been separated in the experimental arm, assigned as the additional comparators and intervened with preventive antiplatelet treatment alternative to clopidogrel. Clinical and non-clinical outcome measures are expected to be compared between parallel study groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistamedi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tbilisi State Medical University
- Responsible party
- Sponsor
- Investigators
- Levan Jijeishvili, MD, MPH, Study director, Vistamedi Ltd., Tbilisi GeorgiaKonstantine Liluashvili, MD., PH.D., Principal investigator, Tbilisi State Medical UniversityTornike Batavani, MD, MPH, Study chair, Vistamedi Ltd. Tbilisi, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665919
- Sponsor's protocol ID
- BREC-TSMU#2-2023/103
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2024
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After deidentification of the data records, the deidentified IPD used for the results section intended for article publication will be shared. The data set will contain certain demographics, risk factors, cardiovascular morbidity, co-morbidity, coronary angiography, doppler-echocardiography, medication selection records of intervention and control group patients as well as CYP2C19 gene \*2, \*3 allele profile of the intervention group patients. Meta-data in the form of tables, figures, text or appendices will be available as well. The study protocol, variable and recorded data coding, statistical analysis plan and informed consent form will be shared as well.
Publications
Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
PubMed 35016208N. Mikaia, L. Jijeishvili, K. Liluashvili, M. Sebiskveradze, Z. Kavtaria, L. Bakashvili, M. Okujava, Implementation of molecular markers targeting thrombosis-related conditions in the real clinical practice, Clinica Chimica Acta, Volume 558, Supplement 1, 2024, 119263, ISSN 0009-8981, https://doi.org/10.1016/j.cca.2024.119263. (https://www.sciencedirect.com/science/article/pii/S0009898124015043)
Zhang Y, Shi XJ, Peng WX, Han JL, Lin BD, Zhang R, Zhang YN, Yan JL, Wei JJ, Wang YF, Chen SW, Nan N, Fang ZW, Zeng Y, Lin Y. Impact of Implementing CYP2C19 Genotype-Guided Antiplatelet Therapy on P2Y12 Inhibitor Selection and Clinical Outcomes in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention: A Real-World Study in China. Front Pharmacol. 2021 Jan 20;11:582929. doi: 10.3389/fphar.2020.582929. eCollection 2020.
PubMed 33551797Beitelshees AL, Stevenson JM, El Rouby N, Dillon C, Empey PE, Fielstein EM, Johnson JA, Limdi NA, Ong HH, Franchi F, Angiolillo DJ, Peterson JF, Rosenman MB, Skaar TC, Tuteja S, Cavallari LH; IGNITE Pharmacogenetics Working Group. Evaluating the extent of reusability of CYP2C19 genotype data among patients genotyped for antiplatelet therapy selection. Genet Med. 2020 Nov;22(11):1898-1902. doi: 10.1038/s41436-020-0894-2. Epub 2020 Jul 17.
PubMed 32678355Galli M, Franchi F, Rollini F, Angiolillo DJ. Role of platelet function and genetic testing in patients undergoing percutaneous coronary intervention. Trends Cardiovasc Med. 2023 Apr;33(3):133-138. doi: 10.1016/j.tcm.2021.12.007. Epub 2021 Dec 20.
PubMed 34936903Leopold JA, Loscalzo J. Emerging Role of Precision Medicine in Cardiovascular Disease. Circ Res. 2018 Apr 27;122(9):1302-1315. doi: 10.1161/CIRCRESAHA.117.310782.
PubMed 29700074Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3.
PubMed 31479209Vyas A, Bash LD, Patel MD, Simpson RJ Jr. Changes in Treatment Patterns and Incremental Health Care Utilization Due to P2Y12-Associated Complications in Patients with Acute Coronary Syndrome. J Manag Care Spec Pharm. 2017 Sep;23(9):947-956. doi: 10.18553/jmcp.2017.23.9.947.
PubMed 28854078Johnson SG, Gruntowicz D, Chua T, Morlock RJ. Financial Analysis of CYP2C19 Genotyping in Patients Receiving Dual Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention. J Manag Care Spec Pharm. 2015 Jul;21(7):552-7. doi: 10.18553/jmcp.2015.21.7.552.
PubMed 26108379Madan M, Abbott JD, Lennon R, So DYF, MacDougall AM, McLaughlin MA, Murthy V, Saw J, Rihal C, Farkouh ME, Pereira NL, Goodman SG; TAILOR-PCI Investigators *. Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Jun 21;11(12):e024709. doi: 10.1161/JAHA.121.024709. Epub 2022 Jun 14.
PubMed 35699175Nazir S, Ahuja KR, Virk HUH, Elzanaty A, Waheed TA, Changal KH, Wohlfarth K, Lakhter V, Grande RD, Eltahawy EA. A meta-analysis of efficacy and safety of genotype-guided versus standard of care treatment strategies in selecting antiplatelet therapy in patients with acute coronary syndrome. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):788-794. doi: 10.1002/ccd.28860. Epub 2020 Apr 3.
PubMed 32243053Nguyen AB, Cavallari LH, Rossi JS, Stouffer GA, Lee CR. Evaluation of race and ethnicity disparities in outcome studies of CYP2C19 genotype-guided antiplatelet therapy. Front Cardiovasc Med. 2022 Aug 23;9:991646. doi: 10.3389/fcvm.2022.991646. eCollection 2022.
PubMed 36082121Jourdi G, Godier A, Lordkipanidze M, Marquis-Gravel G, Gaussem P. Antiplatelet Therapy for Atherothrombotic Disease in 2022-From Population to Patient-Centered Approaches. Front Cardiovasc Med. 2022 Jan 28;9:805525. doi: 10.3389/fcvm.2022.805525. eCollection 2022.
PubMed 35155631Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372.
PubMed 31116395Palmerini T, Della Riva D, Benedetto U, Bacchi Reggiani L, Feres F, Abizaid A, Gilard M, Morice MC, Valgimigli M, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Colombo A, Chieffo A, Sangiorgi D, Biondi-Zoccai G, Genereux P, Angelini GD, Pufulete M, White J, Bhatt DL, Stone GW. Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. Eur Heart J. 2017 Apr 7;38(14):1034-1043. doi: 10.1093/eurheartj/ehw627.
PubMed 28110296
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI
- ClinicalTrials.gov ID
- NCT06665919
- Acronym / sponsor ID
- BREC-TSMU#2-2023/103
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events, Bleeding, Hospitalisations
- Keywords
- CYP2C19 Genotype-guided antiplatelet treatment, Clopidogrel Resistance, Double Antiplatelet Treatment, Chronic Coronary Artery Disease, Implementation of Genotype-guided Medication Treatment, Outcome Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Vistamedi Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tbilisi State Medical University
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The concept of the study is based on current evidence from multiple genetic and clinical studies. At this stage of development preventive treatment of chronic coronary artery disease after ePCI is challenged by risks related to multi-morbidity, recurrent MACCEs and bleeding. Scientific evidence broadly supports pharmacogenetic approaches for routine use of P2Y12 inhibitors (clopidogrel or alternative). Clopidogrel remains the most commonly used P2Y12 inhibitor in the post-ePCI settings. Along with disease-related and co-morbid factors treatment effects are influenced by the variability of the CYP2C19 genotype in the population, which significantly increases the risk of MACCE in loss of function allele (LoF) carriers even with conventional clopidogrel treatment. To improve treatment, a pharmacogenetic expediency model for drug selection is introduced. CYP2C19 allele genotype-guided clopidogrel or an alternative P2Y12 inhibitor treatment is based on robust evidence.
The study aimed to learn the comparative benefits of CYP2C19 genotype-guided versus conventional clopidogrel treatment selection applied in real clinical practice for preventing adverse cardiovascular events after ePCI in chronic coronary artery disease.
For this purpose, the randomized parallel-group controlled study for CYP2C19 genotype-guided clopidogrel treatment outcomes evaluation for chronic coronary artery disease after the ePCI in real-world practice was conducted.
The study addressed research-specific objectives:
- forming and random allocating of participants into study arms for CYP2C19 allele genotype-guided versus conventional clopidogrel treatment,
- ensuring RT-PCR based assay for CYP2C19 *2, *3 LoF alleles detection in randomly selected study participants and forming the experimental study groups,
- characterizing clinical traits of study participants and observing adverse clinical events during the 12-month course of study intervention treatment;
- evaluating the clinical and non-clinical study outcomes. Following the completion of the informed consent, 283 patients eligible for inclusion and exclusion criteria have been enrolled in the study and randomly allocated into two groups. 83 participants created the control group. They did not undergo CYP2C19 genotyping and received conventional antiplatelet treatment based on clopidogrel. 200 participants were tested for CYP2C19 *2, *3 allele genotype. 157 of those who revealed normal CYP2C19 *2, *3 allele genotype received conventional preventive antiplatelet treatment based on clopidogrel and created a separate experimental arm. 43 participants who revealed CYP2C19 *2, *3 LoF allele genotype required preventive antiplatelet treatment alternative to clopidogrel - based on ticagrelor or prasugrel were allocated into another separate experimental arm and assigned as the perspective arm for further study.
Before inclusion, informed consent was obtained from all study participants (or their legal representatives).
The randomization and study arm allocation processes were blinded for participants, healthcare teams providing medical care and study outcomes assessors. Nevertheless, after randomization and genetic testing, CYP2C19 allele genotyping results were disclosed to the medical care team and study participants to make ongoing clinical management safe and transparent but remained blinded for study outcomes assessors.
RT-PCR-based laboratory assay for CYP2C19 *2, *3 alleles genotyping was carried out only once after randomization for each study participant allocated into the experimental group. Tests were performed in the diagnostic laboratory of Vistamedi Ltd served as the central study laboratory.
The laboratory test report was provided to the authenticated investigator and as well as participant and entered in the study data report form.
Regular healthcare teams conducted clinical management of study participants in a real practice environment including medication treatment under conventional guideline recommendations were detected and initially reported major adverse cardiovascular outcomes, other adverse events, or additional clinical conditions diagnosed or study-related circumstances emerged through the study follow-up period up to the end of the study. Study participants (or their legal representatives) were also allowed to report adverse clinical outcomes, events or emerging circumstances.
For a study participant, the expected end of the study is defined as the end date of the 12-month follow-up from the date of the index ePCI. However, in the case of the clinical endpoint which corresponded to and defined the study outcome measure, the date of such endpoint event was determined as the end of the study, even if earlier than 12 months from the index ePCI.
The study participant could terminate participation by his or her independent decision, from any time of the research and for any reason, which could or could not be established.
Early withdrawal of a participant from the study was considered reasonable if there was repeated non-adherence to the treatment of study interest, rather than sporadic, or when there was preferred to terminate treatment based on the justified best interests of the participant.
Clinical outcomes conventionally defined by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the US Food and Drug Administration (FDA), the Academic Research Consortium for High Bleeding Risk (ARC-HBR) and WHO have been measured by clinical endpoints developed over the course of clinical cases.
Certain elements of the Coronary Revascularization Outcome Questionnaire (CROQ) and Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure profile were used for measuring of Patient-Reported Outcomes (PROs).
Study results were also analyzed using other non-clinical outcome measures that characterized the effectiveness of СYP2C19 genotype-guided P2Y12 inhibitor treatment utilization in real practice.
Data from each study participant were entered into a CRF, the form of which was the same for all participants and study centers.
Study data are collected, stored, and processed into a custom-designed electronic database. Identifiers, study variables and record data are validated with codes to ensure personal data protection.
Personal data, code keys and definitions, and research data are warehoused in separate databases. Only authenticated researchers have access to them. Research data collection centers do not have an internet connection or any other access to the database files.
Study data processing is only allowed by the study procedures given in the study protocol.
After the data collection, the database containing the personal data of the study participants will be deleted.
The de-identified electronic database will be stored after the end of the study for further research purposes for an indefinite period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- To evaluate CYP2C19 allele genotype-guided clopidogrel treatment outcomes after the ePCI study participants were randomly allocated into parallel study arms. Experimental arm participants have undergone CYP2C19 genotyping. Carriers of normal *2, *3 alleles - "normal metabolizers" phenotype separated as the experimental arm and participants randomly allocated in the comparators arm without CYP2C19 genotyping - the "unspecified metabolizers" phenotype, have been intervened with clopidogrel-based preventive antiplatelet treatment. Carriers of LoF *2, *3 alleles - the "poor metabolizers" phenotype, have been separated in the experimental arm, assigned as the additional comparators and intervened with preventive antiplatelet treatment alternative to clopidogrel. Clinical and non-clinical outcome measures are expected to be compared between parallel study groups.
| Arm | Type | Receives |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Experimental | Other: CYP2C19 Genotype-Guided Clopidogrel Treatment157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA *2, *3 carriers. |
| Passive Metabolizers of Clopidogrel | Experimental | Other: CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF *2, *3 alleles carriers. |
| Unspecified Metabolizers of Clopidogrel | Active comparator | Other: The Conventional Clopidogrel Treatment83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP2C19 Genotype-Guided Clopidogrel TreatmentClopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or an antiplatelet drug (clopidogrel) combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel). | Other | Normal Metabolizers of Clopidogrel |
| CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to ClopidogrelAn antiplatelet drug alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor, or prasugrel). | Other | Passive Metabolizers of Clopidogrel |
| The Conventional Clopidogrel TreatmentClopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or clopidogrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel). | Other | Unspecified Metabolizers of Clopidogrel |
Primary outcome
Number of Study Participants Who Died From Any Cause (Death From Any Cause)
Time frame: within a 12-month of the study follow-up
The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause)
Time frame: within a 12-month of the study follow-up
The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause)
Time frame: within a 12-month of the study follow-up
The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
7 secondary outcomes
Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Major Bleeding (Major Bleeding)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event)
Time frame: within a 12-month of the study follow-up
Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization)
Time frame: within a 12-month of the study follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35016208Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
- BackgroundN. Mikaia, L. Jijeishvili, K. Liluashvili, M. Sebiskveradze, Z. Kavtaria, L. Bakashvili, M. Okujava, Implementation of molecular markers targeting thrombosis-related conditions in the real clinical practice, Clinica Chimica Acta, Volume 558, Supplement 1, 2024, 119263, ISSN 0009-8981, https://doi.org/10.1016/j.cca.2024.119263. (https://www.sciencedirect.com/science/article/pii/S0009898124015043)
- Background: PubMed 33551797Zhang Y, Shi XJ, Peng WX, Han JL, Lin BD, Zhang R, Zhang YN, Yan JL, Wei JJ, Wang YF, Chen SW, Nan N, Fang ZW, Zeng Y, Lin Y. Impact of Implementing CYP2C19 Genotype-Guided Antiplatelet Therapy on P2Y12 Inhibitor Selection and Clinical Outcomes in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention: A Real-World Study in China. Front Pharmacol. 2021 Jan 20;11:582929. doi: 10.3389/fphar.2020.582929. eCollection 2020.
- Background: PubMed 32678355Beitelshees AL, Stevenson JM, El Rouby N, Dillon C, Empey PE, Fielstein EM, Johnson JA, Limdi NA, Ong HH, Franchi F, Angiolillo DJ, Peterson JF, Rosenman MB, Skaar TC, Tuteja S, Cavallari LH; IGNITE Pharmacogenetics Working Group. Evaluating the extent of reusability of CYP2C19 genotype data among patients genotyped for antiplatelet therapy selection. Genet Med. 2020 Nov;22(11):1898-1902. doi: 10.1038/s41436-020-0894-2. Epub 2020 Jul 17.
- Background: PubMed 34936903Galli M, Franchi F, Rollini F, Angiolillo DJ. Role of platelet function and genetic testing in patients undergoing percutaneous coronary intervention. Trends Cardiovasc Med. 2023 Apr;33(3):133-138. doi: 10.1016/j.tcm.2021.12.007. Epub 2021 Dec 20.
- Background: PubMed 29700074Leopold JA, Loscalzo J. Emerging Role of Precision Medicine in Cardiovascular Disease. Circ Res. 2018 Apr 27;122(9):1302-1315. doi: 10.1161/CIRCRESAHA.117.310782.
- Background: PubMed 31479209Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3.
- Background: PubMed 28854078Vyas A, Bash LD, Patel MD, Simpson RJ Jr. Changes in Treatment Patterns and Incremental Health Care Utilization Due to P2Y12-Associated Complications in Patients with Acute Coronary Syndrome. J Manag Care Spec Pharm. 2017 Sep;23(9):947-956. doi: 10.18553/jmcp.2017.23.9.947.
- Background: PubMed 26108379Johnson SG, Gruntowicz D, Chua T, Morlock RJ. Financial Analysis of CYP2C19 Genotyping in Patients Receiving Dual Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention. J Manag Care Spec Pharm. 2015 Jul;21(7):552-7. doi: 10.18553/jmcp.2015.21.7.552.
- Background: PubMed 35699175Madan M, Abbott JD, Lennon R, So DYF, MacDougall AM, McLaughlin MA, Murthy V, Saw J, Rihal C, Farkouh ME, Pereira NL, Goodman SG; TAILOR-PCI Investigators *. Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Jun 21;11(12):e024709. doi: 10.1161/JAHA.121.024709. Epub 2022 Jun 14.
- Background: PubMed 32243053Nazir S, Ahuja KR, Virk HUH, Elzanaty A, Waheed TA, Changal KH, Wohlfarth K, Lakhter V, Grande RD, Eltahawy EA. A meta-analysis of efficacy and safety of genotype-guided versus standard of care treatment strategies in selecting antiplatelet therapy in patients with acute coronary syndrome. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):788-794. doi: 10.1002/ccd.28860. Epub 2020 Apr 3.
- Background: PubMed 36082121Nguyen AB, Cavallari LH, Rossi JS, Stouffer GA, Lee CR. Evaluation of race and ethnicity disparities in outcome studies of CYP2C19 genotype-guided antiplatelet therapy. Front Cardiovasc Med. 2022 Aug 23;9:991646. doi: 10.3389/fcvm.2022.991646. eCollection 2022.
- Clopidogrel, Drug Usage Statistics, United States, 2013 - 2022Link provided by the sponsor.
- CPIC® Guideline for Clopidogrel and CYP2C19Link provided by the sponsor.
- PharmGKB Clinical Annotations of Clopidogrel, information about variant-drug pairs based primarily on variant annotations and incorporating variant-specific prescribing guidance from clinical guidelines and FDA-approved drug labels, when available.Link provided by the sponsor.
- Dean L, Kane M. Clopidogrel Therapy and CYP2C19 Genotype. 2012 Mar 8 \[Updated 2022 Dec 1\]. In: Pratt VM, Scott SA, Pirmohamed M, et al., editors. Medical Genetics Summaries \[Internet\]. Bethesda (MD): National Center for Biotechnology Information (US); 20Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. After deidentification of the data records, the deidentified IPD used for the results section intended for article publication will be shared. The data set will contain certain demographics, risk factors, cardiovascular morbidity, co-morbidity, coronary angiography, doppler-echocardiography, medication selection records of intervention and control group patients as well as CYP2C19 gene *2, *3 allele profile of the intervention group patients. Meta-data in the form of tables, figures, text or appendices will be available as well. The study protocol, variable and recorded data coding, statistical analysis plan and informed consent form will be shared as well.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levan Jijeishvili, MD, MPH study director
Vistamedi Ltd., Tbilisi Georgia
Konstantine Liluashvili, MD., PH.D. principal investigator
Tbilisi State Medical University
Tornike Batavani, MD, MPH study chair
Vistamedi Ltd. Tbilisi, Georgia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel and The Conventional Clopidogrel Treatment in people with Coronary Artery Disease and Clopidogrel Resistance, run by Vistamedi Ltd. at 4 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Study Participants Who Died From Any Cause (Death From Any Cause) (time frame: within a 12-month of the study follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06665919, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.