Actively Recruiting

Age: 18Years +
All Genders
NCT06292117

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

Led by University of Virginia · Updated on 2026-05-06

350

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women at least 18 years of age
  • Presenting with symptoms of acute ischemic stroke or transient ischemic attack without contraindications to dual antiplatelet therapy at screening
  • Presenting within 24 hours of symptom onset, or within 24-96 hours if already on or planned to receive dual antiplatelet therapy
Not Eligible

You will not qualify if you...

  • Receiving therapeutic anticoagulation or have a clear reason to start anticoagulation after the event (e.g., known atrial fibrillation)
  • History of allogeneic bone marrow transplant
  • History of liver transplant
  • Unable to consent and no surrogate available to consent on your behalf

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

A

Andrew Weko, MPH

CONTACT

R

Rachael M Stone, PharmD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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