Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06292117
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CYP2C19 Genotype — OTHER
    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)

Study Details

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.

Key Dates

Start date
Apr 16, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
350 participants (estimated)

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Drew Weko, MPH

Find similar trials in Charlottesville, VA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Virginia· Charlottesville, VA

Related Studies