Recruiting

CYP2C19 Assay

Sponsor:

University of Virginia

Code:

NCT06292117

Conditions

Ischemic Stroke

CYP2C19 Polymorphism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYP2C19 Genotype

Study Details

Brief summary:

The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.

The main questions this study aims to answer are:

  • What are the best strategies to implement this genetic test in the hospital?
  • Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?

Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.

Conditions

Ischemic Stroke

CYP2C19 Polymorphism

Study ID

NCT06292117

Start date

Apr 16, 2024

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women at least 18 years of age
  • Presenting with symptoms of acute ischemic stroke or transient ischemic attack and without contraindications to dual antiplatelet therapy at time of clinical research coordinator screening
  • Presenting within 24 of symptom onset; or, within 24-96 hours of symptom onset IF planned to receive or already on dual antiplatelet therapy

Exclusion Criteria:

  • Receiving therapeutic anticoagulation or clear indication for initiation of anticoagulation after event (e.g., known atrial fibrillation)
  • History of allogeneic bone marrow transplant
  • History of liver transplant
  • Subject who is unable to consent and does not have a surrogate available to consent on their behalf

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Interventions

CYP2C19 Genotype

qPCR-based genotyping assay interrogating all Association for Molecular Pathology (AMP) recommended Tier 1 and Tier 2 single nucleotide polymorphisms (SNPs) for CYP2C19 (\*2, \*3, \*4, \*5, \*6, \*7, \*8, \*9, \*10, \*17, \*35)

Primary outcome measure

  • Percentage of patients discharged from University of Virginia (UVA) Health on dual antiplatelet therapy with a diagnosis of AIS/TIA meeting eligibility criteria upon presentation that are successfully genotyped [ Time Frame: At time of participant discharge from hospital; approximately 1-5 days ]
  • Average turnaround time of genotype result from time of collection of blood sample to time result is entered into the electronic health record [ Time Frame: From time of participant blood draw up to 21 days after ]

Central Contacts and Locations

Central contacts

Andrew Weko, MPH

434-297-6777crx3qp@uvahealth.org

Rachael M Stone, PharmD

zny6vz@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

University of Virginia

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • pharmacogenomics
  • pharmacogenetics
  • dual antiplatelet therapy
  • secondary prevention of ischemic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-05-06.