Genetic Testing of CYP2C19 in Prognostic Evaluation of Long-Term Major Adverse Cardiac and Vascular Events (UF-GENOTYPE)

March 30, 2026 updated by: University of Florida

Impact of CYP2C19 Gene Polymorphism on Long-term Major Adverse Cardiac and Vascular Events

Several studies have shown that the efficacy of clopidogrel for secondary prevention of major adverse cardiovascular events (MACE), including acute coronary syndrome, depends on the polymorphism of the CYP2C19 gene. However, studies with large sample sizes and long-term follow-up are missing. Moreover, the impact of this polymorphism on the risk of major adverse limb events (MALE), particularly in patients with peripheral artery disease of the lower limb, is unexplored. Additionally, the impact of CYP2C19 gene polymorphism on clopidogrel effectiveness in preventing recurrent stroke in diverse populations is unknown since most of the data are from Asian ancestry populations. We hypothesize that patients with CYP2C19 gene loss of function alleles are at high risk of MACE and MALE compared to those without loss of function alleles at long-term follow-up. We propose to assess MACE and MALE in a large cohort of patients with available CYP2C19 genotypes treated at the University of Florida Health to evaluate the impact of CYP2C19 gene polymorphisms on the risk of new or recurrent events at long-term follow-up. Our specific aims are Aim 1) to determine the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MACE (a composite of all-cause death, non-fatal MI, and non-fatal stroke) at long-term follow-up; Aim 2) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MALE (a composite of limb amputations, chronic threatening limb ischemia, acute limb ischemia, and limb revascularization) at long-term follow-up; and Aim 3) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of cerebrovascular events (CVE, a composite of any stroke and transient ischemic attack) at long-term follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

13000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health
      • Jacksonville, Florida, United States, 32209
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with systemic atherosclerosis.

Description

Inclusion Criteria:

  • All patients aged ≥18 years with available CYP2C19 genotyping results obtained within the predefined period.

Exclusion Criteria:

  • Absence of CYP2C19 genotyping results obtained within the predefined period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cytochrome P450 2C19 Loss-of-function
Patients carriers of a Cytochrome P450 2C19 loss-of-function allele (i.e., *2 or *3)
Cytochrome P450 2C19 Non-loss-of-function
Patients without a Cytochrome P450 2C19 loss-of-function allele.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 5 years
Defined as the composite of all-cause death, non-fatal MI, ornon-fatal stroke
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse limb events
Time Frame: 5 years
A composite of limb amputations, chronic threatening limb ischemia, acute limb ischemia, or limb revascularization.
5 years
Net adverse clinical events
Time Frame: 5 years
a composite of all-cause death, myocardial infarction, stroke, and major bleeding.
5 years
Cerebrovascular event
Time Frame: 5 years
A composite of any stroke or transient ischemic attack.
5 years
Major bleeding
Time Frame: 5 years
Defined in accordance with the Bleeding Academic research consortium as BARC type 3 to 5 bleeding.
5 years
Minor bleeding
Time Frame: 5 years
Defined in accordance with the Bleeding Academic research consortium as BARC type 1 to 2 bleeding.
5 years
Clinically relevant bleeding
Time Frame: 5 years
Defined in accordance with the Bleeding Academic research consortium as BARC type 2 to 5 bleeding.
5 years
Venous thromboembolic disease
Time Frame: 5 years
Defined as the composite of deep vein thrombosis or pulmonary embolism.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202302158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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