The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models

Summary

The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug metabolism.

The study aimed to answer two research questions:

* Does CYP2C19 genotype-guided clopidogrel treatment provide better clinical outcomes when compared with conventional treatment selection led without CYP2C19 genotyping?
* Can CYP2C19 genotype-guided antiplatelet treatment be beneficially applied in real-world clinical practice?

After obtaining the informed consent eligible study participants screened by inclusion and exclusion criteria were randomized and allocated into two groups:

* for whom the CYP2C19 genotype-guided clopidogrel treatment has been applied - the experimental group,
* for whom conventional clopidogrel has been applied without CYP2C19 genotyping - the control group.

The experimental group participants underwent CYP2C19 genotyping. Study participants with CYP2C19 normal function alleles (NFA) \*2, \*3 genotypes constituted the separate experimental arm and received clopidogrel-based preventive antiplatelet treatment.

Participants with CYP2C19 \*2 and \*3 loss of function (LoF) alleles were allocated to the separate experimental group and received preventive antiplatelet treatment alternative to clopidogrel.

Study participants who had not undergone CYP2C19 genotyping and received conventional preventive antiplatelet treatment with clopidogrel were assigned as active comparators.

All participants in the experimental and comparator groups underwent standard clinical investigations by current guideline recommendations for:

* the initial assessment,
* follow-up and detection of major adverse cardiovascular events. All patients received the conventional drug treatment by current guideline recommendations for chronic coronary artery disease and comorbid condition management and adverse cardiovascular events prevention.

The main research outcome measures include:

* evaluating clinical outcomes of CYP2C19 genotype-guided antiplatelet treatment application,
* describing models for application of CYP2C19 genotype-guided antiplatelet treatment,
* learning about potential access points to the real practice process pipeline for implementation of genotype-guided medication treatment.

Conditions

• Coronary Artery Disease
• Clopidogrel Resistance
• Coronary Thrombosis
• Adverse Cardiac Events
• Bleeding
• Hospitalisations
• Death
• Death From Cardiovascular Disease

Interventions

OTHER

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).

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).

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).

Sponsors & Collaborators

• Tbilisi State Medical University

  collaborator OTHER

• Vistamedi Ltd.

  lead INDUSTRY

Principal Investigators

• Levan Jijeishvili, MD, MPH · Vistamedi Ltd., Tbilisi Georgia

• Konstantine Liluashvili, MD., PH.D. · Tbilisi State Medical University

• Tornike Batavani, MD, MPH · Vistamedi Ltd. Tbilisi, Georgia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-15

Primary Completion

2025-05-15

Completion

2025-07-05

Countries

• Georgia

Study Locations