The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
NCT ID: NCT06665919
Last Updated: 2025-09-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
283 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-15
Study Completion Date
2025-07-05
Brief Summary
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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.
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.
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Detailed Description
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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.
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
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Coronary Artery Disease
Clopidogrel Resistance
Coronary Thrombosis
Adverse Cardiac Events
Bleeding
Hospitalisations
Death
Death From Cardiovascular Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Study Groups
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Normal Metabolizers of Clopidogrel
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.
Group Type
EXPERIMENTAL
CYP2C19 Genotype-Guided Clopidogrel Treatment
Intervention Type
OTHER
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).
Passive Metabolizers of Clopidogrel
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.
Group Type
EXPERIMENTAL
CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel
Intervention Type
OTHER
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).
Unspecified Metabolizers of Clopidogrel
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.
Group Type
ACTIVE_COMPARATOR
The Conventional Clopidogrel Treatment
Intervention Type
OTHER
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).
Interventions
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CYP2C19 Genotype-Guided Clopidogrel Treatment
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).
Intervention Type
OTHER
CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel
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).
Intervention Type
OTHER
The Conventional Clopidogrel Treatment
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).
Intervention Type
OTHER
Eligibility Criteria
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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;
* 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.
* 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.
Minimum Eligible Age
35 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tbilisi State Medical University
OTHER
Sponsor Role
collaborator
Vistamedi Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Levan Jijeishvili, MD, MPH
Role: STUDY_DIRECTOR
Vistamedi Ltd., Tbilisi Georgia
Konstantine Liluashvili, MD., PH.D.
Role: PRINCIPAL_INVESTIGATOR
Tbilisi State Medical University
Tornike Batavani, MD, MPH
Role: STUDY_CHAIR
Vistamedi Ltd. Tbilisi, Georgia
Locations
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1st University Clinic of the Tbilisi State Medical University
Tbilisi, , Georgia
Site Status
Cardio Expert Ltd., Clinic Cardio
Tbilisi, , Georgia
Site Status
T. Oragvelidze Cardiology Center
Tbilisi, , Georgia
Site Status
Tbilisi Institute of Medicine
Tbilisi, , Georgia
Site Status
Countries
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Georgia
References
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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.
Reference Type
BACKGROUND
N. 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)
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Beitelshees 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.
Reference Type
BACKGROUND
Galli 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.
Reference Type
BACKGROUND
Leopold 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.
Reference Type
BACKGROUND
Claassens 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.
Reference Type
BACKGROUND
Vyas 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.
Reference Type
BACKGROUND
Johnson 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.
Reference Type
BACKGROUND
Madan 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.
Reference Type
BACKGROUND
Nazir 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.
Reference Type
BACKGROUND
Nguyen 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.
Reference Type
BACKGROUND
Jourdi 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.
Reference Type
BACKGROUND
Urban 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.
Reference Type
BACKGROUND
Palmerini 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.
Reference Type
BACKGROUND
Aradi D, Storey RF, Komocsi A, Trenk D, Gulba D, Kiss RG, Husted S, Bonello L, Sibbing D, Collet JP, Huber K; Working Group on Thrombosis of the European Society of Cardiology. Expert position paper on the role of platelet function testing in patients undergoing percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(4):209-15. doi: 10.1093/eurheartj/eht375. Epub 2013 Sep 25. No abstract available.
Reference Type
BACKGROUND
Capodanno D, Angiolillo DJ. Personalised antiplatelet therapies for coronary artery disease: what the future holds. Eur Heart J. 2023 Aug 22;44(32):3059-3072. doi: 10.1093/eurheartj/ehad362.
Reference Type
BACKGROUND
van der Sangen NMR, Rozemeijer R, Chan Pin Yin DRPP, Valgimigli M, Windecker S, James SK, Buccheri S, Ten Berg JM, Henriques JPS, Voskuil M, Kikkert WJ. Patient-tailored antithrombotic therapy following percutaneous coronary intervention. Eur Heart J. 2021 Mar 7;42(10):1038-1046. doi: 10.1093/eurheartj/ehaa1097.
Reference Type
BACKGROUND
Cavallari LH, Beitelshees AL, Blake KV, Dressler LG, Duarte JD, Elsey A, Eichmeyer JN, Empey PE, Franciosi JP, Hicks JK, Holmes AM, Jeng L, Lee CR, Lima JJ, Limdi NA, Modlin J, Obeng AO, Petry N, Pratt VM, Skaar TC, Tuteja S, Voora D, Wagner M, Weitzel KW, Wilke RA, Peterson JF, Johnson JA. The IGNITE Pharmacogenetics Working Group: An Opportunity for Building Evidence with Pharmacogenetic Implementation in a Real-World Setting. Clin Transl Sci. 2017 May;10(3):143-146. doi: 10.1111/cts.12456. Epub 2017 Mar 14. No abstract available.
Reference Type
BACKGROUND
El Rouby N, Alrwisan A, Langaee T, Lipori G, Angiolillo DJ, Franchi F, Riva A, Elsey A, Johnson JA, Cavallari LH, Winterstein AG. Clinical Utility of Pharmacogene Panel-Based Testing in Patients Undergoing Percutaneous Coronary Intervention. Clin Transl Sci. 2020 May;13(3):473-481. doi: 10.1111/cts.12729. Epub 2020 Jan 16.
Reference Type
BACKGROUND
Davis BH, DeFrank G, Limdi NA, Harada S. Validation of the Spartan RXCYP2C19 Genotyping Assay Utilizing Blood Samples. Clin Transl Sci. 2020 Mar;13(2):260-264. doi: 10.1111/cts.12714. Epub 2019 Nov 29.
Reference Type
BACKGROUND
Lee CR, Sriramoju VB, Cervantes A, Howell LA, Varunok N, Madan S, Hamrick K, Polasek MJ, Lee JA, Clarke M, Cicci JD, Weck KE, Stouffer GA. Clinical Outcomes and Sustainability of Using CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. Circ Genom Precis Med. 2018 Apr;11(4):e002069. doi: 10.1161/CIRCGEN.117.002069.
Reference Type
BACKGROUND
Zhang H, Xiang Q, Liu Z, Mu G, Xie Q, Zhou S, Ma L, Wang Z, Hu K, Wang Z, Cui Y. Genotype-guided antiplatelet treatment versus conventional therapy: A systematic review and meta-analysis. Br J Clin Pharmacol. 2021 May;87(5):2199-2215. doi: 10.1111/bcp.14637. Epub 2020 Dec 29.
Reference Type
BACKGROUND
Pilling LC, Turkmen D, Fullalove H, Atkins JL, Delgado J, Kuo CL, Kuchel GA, Ferrucci L, Bowden J, Masoli JAH, Melzer D. Analysis of CYP2C19 genetic variants with ischaemic events in UK patients prescribed clopidogrel in primary care: a retrospective cohort study. BMJ Open. 2021 Dec 13;11(12):e053905. doi: 10.1136/bmjopen-2021-053905.
Reference Type
BACKGROUND
Gower MN, Ratner LR, Williams AK, Rossi JS, Stouffer GA, Lee CR. Clinical Utility of CYP2C19 Genotype-Guided Antiplatelet Therapy in Patients at Risk of Adverse Cardiovascular and Cerebrovascular Events: A Review of Emerging Evidence. Pharmgenomics Pers Med. 2020 Jul 27;13:239-252. doi: 10.2147/PGPM.S231475. eCollection 2020.
Reference Type
BACKGROUND
Notarangelo FM, Maglietta G, Bevilacqua P, Cereda M, Merlini PA, Villani GQ, Moruzzi P, Patrizi G, Malagoli Tagliazucchi G, Crocamo A, Guidorossi A, Pigazzani F, Nicosia E, Paoli G, Bianchessi M, Comelli MA, Caminiti C, Ardissino D. Pharmacogenomic Approach to Selecting Antiplatelet Therapy in Patients With Acute Coronary Syndromes: The PHARMCLO Trial. J Am Coll Cardiol. 2018 May 1;71(17):1869-1877. doi: 10.1016/j.jacc.2018.02.029. Epub 2018 Mar 11.
Reference Type
BACKGROUND
Cavallari LH, Lee CR, Beitelshees AL, Cooper-DeHoff RM, Duarte JD, Voora D, Kimmel SE, McDonough CW, Gong Y, Dave CV, Pratt VM, Alestock TD, Anderson RD, Alsip J, Ardati AK, Brott BC, Brown L, Chumnumwat S, Clare-Salzler MJ, Coons JC, Denny JC, Dillon C, Elsey AR, Hamadeh IS, Harada S, Hillegass WB, Hines L, Horenstein RB, Howell LA, Jeng LJB, Kelemen MD, Lee YM, Magvanjav O, Montasser M, Nelson DR, Nutescu EA, Nwaba DC, Pakyz RE, Palmer K, Peterson JF, Pollin TI, Quinn AH, Robinson SW, Schub J, Skaar TC, Smith DM, Sriramoju VB, Starostik P, Stys TP, Stevenson JM, Varunok N, Vesely MR, Wake DT, Weck KE, Weitzel KW, Wilke RA, Willig J, Zhao RY, Kreutz RP, Stouffer GA, Empey PE, Limdi NA, Shuldiner AR, Winterstein AG, Johnson JA; IGNITE Network. Multisite Investigation of Outcomes With Implementation of CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2018 Jan 22;11(2):181-191. doi: 10.1016/j.jcin.2017.07.022. Epub 2017 Nov 1.
Reference Type
BACKGROUND
AlMukdad S, Elewa H, Al-Badriyeh D. Economic Evaluations of CYP2C19 Genotype-Guided Antiplatelet Therapy Compared to the Universal Use of Antiplatelets in Patients With Acute Coronary Syndrome: A Systematic Review. J Cardiovasc Pharmacol Ther. 2020 May;25(3):201-211. doi: 10.1177/1074248420902298. Epub 2020 Feb 6.
Reference Type
BACKGROUND
Tang B, Wang X, Wang X, Liu L, Ma Z. Genotype-Guided Antiplatelet Therapy Versus Standard Therapy for Patients with Coronary Artery Disease: An Updated Systematic Review and Meta-Analysis. J Pharm Pharm Sci. 2022;25:9-23. doi: 10.18433/jpps32140.
Reference Type
BACKGROUND
Leucht S, Helfer B, Gartlehner G, Davis JM. How effective are common medications: a perspective based on meta-analyses of major drugs. BMC Med. 2015 Oct 2;13:253. doi: 10.1186/s12916-015-0494-1.
Reference Type
BACKGROUND
Yamani N, Unzek S, Mankani MH, Almas T, Musheer A, Qamar H, Farooq S, Shahnawaz W, Fatima K, Figueredo V, Mookadam F. Does individualized guided selection of antiplatelet therapy improve outcomes after percutaneous coronary intervention? A systematic review and meta-analysis. Ann Med Surg (Lond). 2022 Jun 18;79:103964. doi: 10.1016/j.amsu.2022.103964. eCollection 2022 Jul.
Reference Type
BACKGROUND
Lee SH, Jeong YH, Hong D, Choi KH, Lee JM, Park TK, Yang JH, Hahn JY, Choi SH, Gwon HC, Jeong MH, Kim BK, Joo HJ, Chang K, Park Y, Ahn SG, Suh JW, Lee SY, Cho JR, Her AY, Kim HS, Kim MH, Lim DS, Shin ES, Song YB; PTRG-DES Registry Investigators. Clinical Impact of CYP2C19 Genotype on Clopidogrel-Based Antiplatelet Therapy After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):829-843. doi: 10.1016/j.jcin.2023.01.363. Epub 2023 Mar 8.
Reference Type
BACKGROUND
Ingraham BS, Farkouh ME, Lennon RJ, So D, Goodman SG, Geller N, Bae JH, Jeong MH, Baudhuin LM, Mathew V, Bell MR, Lerman A, Fu YP, Hasan A, Iturriaga E, Tanguay JF, Welsh RC, Rosenberg Y, Bailey K, Rihal C, Pereira NL. Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Apr 10;16(7):816-825. doi: 10.1016/j.jcin.2023.01.356.
Reference Type
BACKGROUND
Stys TP, Gedela M, Gowda SN, Bares V, Fanta L, Petrasko M, Hajek C, Larson E, Stys AT. CYP2C19 genotype-directed P2Y12 inhibitor antiplatelet therapy normalizes risk for major adverse cardiovascular events after percutaneous coronary intervention. Indian Heart J. 2021 May-Jun;73(3):281-288. doi: 10.1016/j.ihj.2021.03.004. Epub 2021 Mar 17.
Reference Type
BACKGROUND
Pereira NL, Rihal CS, So DYF, Rosenberg Y, Lennon RJ, Mathew V, Goodman SG, Weinshilboum RM, Wang L, Baudhuin LM, Lerman A, Hasan A, Iturriaga E, Fu YP, Geller N, Bailey K, Farkouh ME. Clopidogrel Pharmacogenetics. Circ Cardiovasc Interv. 2019 Apr;12(4):e007811. doi: 10.1161/CIRCINTERVENTIONS.119.007811.
Reference Type
BACKGROUND
Tuteja S, Glick H, Matthai W, Nachamkin I, Nathan A, Monono K, Carcuffe C, Maslowski K, Chang G, Kobayashi T, Anwaruddin S, Hirshfeld J, Wilensky RL, Herrmann HC, Kolansky DM, Rader DJ, Giri J. Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial. Circ Genom Precis Med. 2020 Feb;13(1):e002640. doi: 10.1161/CIRCGEN.119.002640. Epub 2020 Jan 12.
Reference Type
BACKGROUND
Lee CR, Luzum JA, Sangkuhl K, Gammal RS, Sabatine MS, Stein CM, Kisor DF, Limdi NA, Lee YM, Scott SA, Hulot JS, Roden DM, Gaedigk A, Caudle KE, Klein TE, Johnson JA, Shuldiner AR. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update. Clin Pharmacol Ther. 2022 Nov;112(5):959-967. doi: 10.1002/cpt.2526. Epub 2022 Feb 8.
Reference Type
BACKGROUND
Abdullah-Koolmees H, van Keulen AM, Nijenhuis M, Deneer VHM. Pharmacogenetics Guidelines: Overview and Comparison of the DPWG, CPIC, CPNDS, and RNPGx Guidelines. Front Pharmacol. 2021 Jan 25;11:595219. doi: 10.3389/fphar.2020.595219. eCollection 2020.
Reference Type
BACKGROUND
Dayoub EJ, Seigerman M, Tuteja S, Kobayashi T, Kolansky DM, Giri J, Groeneveld PW. Trends in Platelet Adenosine Diphosphate P2Y12 Receptor Inhibitor Use and Adherence Among Antiplatelet-Naive Patients After Percutaneous Coronary Intervention, 2008-2016. JAMA Intern Med. 2018 Jul 1;178(7):943-950. doi: 10.1001/jamainternmed.2018.0783.
Reference Type
BACKGROUND
Parcha V, Heindl BF, Li P, Kalra R, Limdi NA, Pereira NL, Arora G, Arora P. Genotype-Guided P2Y12 Inhibitor Therapy After Percutaneous Coronary Intervention: A Bayesian Analysis. Circ Genom Precis Med. 2021 Dec;14(6):e003353. doi: 10.1161/CIRCGEN.121.003353. Epub 2021 Oct 21.
Reference Type
BACKGROUND
Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443.
Reference Type
BACKGROUND
Chanfreau-Coffinier C, Friede KA, Plomondon ME, Lee KM, Lu Z, Lynch JA, DuVall SL, Vassy JL, Waldo SW, Cleator JH, Maddox TM, Rader DJ, Assimes TL, Damrauer SM, Tsao PS, Chang KM, Voora D, Giri J, Tuteja S. CYP2C19 Polymorphisms and Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) in the Million Veterans Program. medRxiv [Preprint]. 2023 Oct 26:2023.10.25.23297578. doi: 10.1101/2023.10.25.23297578.
Reference Type
BACKGROUND
Martin J, Williams AK, Klein MD, Sriramoju VB, Madan S, Rossi JS, Clarke M, Cicci JD, Cavallari LH, Weck KE, Stouffer GA, Lee CR. Frequency and clinical outcomes of CYP2C19 genotype-guided escalation and de-escalation of antiplatelet therapy in a real-world clinical setting. Genet Med. 2020 Jan;22(1):160-169. doi: 10.1038/s41436-019-0611-1. Epub 2019 Jul 18.
Reference Type
BACKGROUND
Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, Bhatt DL, Bonello L, Collet JP, Cuisset T, Franchi F, Gross L, Gurbel P, Jeong YH, Mehran R, Moliterno DJ, Neumann FJ, Pereira NL, Price MJ, Sabatine MS, So DYF, Stone GW, Storey RF, Tantry U, Trenk D, Valgimigli M, Waksman R, Angiolillo DJ. Updated Expert Consensus Statement on Platelet Function and Genetic Testing for Guiding P2Y12 Receptor Inhibitor Treatment in Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1521-1537. doi: 10.1016/j.jcin.2019.03.034. Epub 2019 Jun 12.
Reference Type
BACKGROUND
Capodanno D, Angiolillo DJ, Lennon RJ, Goodman SG, Kim SW, O'Cochlain F, So DY, Sweeney J, Rihal CS, Farkouh M, Pereira NL. ABCD-GENE Score and Clinical Outcomes Following Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial. J Am Heart Assoc. 2022 Feb 15;11(4):e024156. doi: 10.1161/JAHA.121.024156. Epub 2022 Feb 8.
Reference Type
BACKGROUND
Al-Abcha A, Radwan Y, Blais D, Mazzaferri EL Jr, Boudoulas KD, Essa EM, Gumina RJ. Genotype-Guided Use of P2Y12 Inhibitors: A Review of Current State of the Art. Front Cardiovasc Med. 2022 Mar 23;9:850028. doi: 10.3389/fcvm.2022.850028. eCollection 2022.
Reference Type
BACKGROUND
Dannenberg L, Afzal S, Czychy N, M'Pembele R, Zako S, Helten C, Mourikis P, Zikeli D, Ahlbrecht S, Trojovsky K, Benkhoff M, Barcik M, Wolff G, Zeus T, Kelm M, Polzin A. Risk prediction of bleeding and MACCE by PRECISE-DAPT score post-PCI. Int J Cardiol Heart Vasc. 2021 Mar 13;33:100750. doi: 10.1016/j.ijcha.2021.100750. eCollection 2021 Apr.
Reference Type
BACKGROUND
Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.
Reference Type
BACKGROUND
Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
Reference Type
BACKGROUND
Luengo-Fernandez R, Walli-Attaei M, Gray A, Torbica A, Maggioni AP, Huculeci R, Bairami F, Aboyans V, Timmis AD, Vardas P, Leal J. Economic burden of cardiovascular diseases in the European Union: a population-based cost study. Eur Heart J. 2023 Dec 1;44(45):4752-4767. doi: 10.1093/eurheartj/ehad583.
Reference Type
BACKGROUND
Crea F, Libby P. Acute Coronary Syndromes: The Way Forward From Mechanisms to Precision Treatment. Circulation. 2017 Sep 19;136(12):1155-1166. doi: 10.1161/CIRCULATIONAHA.117.029870.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://clincalc.com/DrugStats/Drugs/Clopidogrel
Clopidogrel, Drug Usage Statistics, United States, 2013 - 2022
https://cpicpgx.org/guidelines/guideline-for-clopidogrel-and-cyp2c19/
CPIC® Guideline for Clopidogrel and CYP2C19
https://www.pharmgkb.org/chemical/PA449053/clinicalAnnotation
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.
https://www.ncbi.nlm.nih.gov/books/NBK84114/
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); 20
Other Identifiers
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BREC-TSMU#2-2023/103
Identifier Type: -
Identifier Source: org_study_id
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