RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-16
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06292117

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women at least 18 years of age
  2. * 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
  3. * Presenting within 24 of symptom onset; or, within 24-96 hours of symptom onset IF planned to receive or already on dual antiplatelet therapy
  1. * Receiving therapeutic anticoagulation or clear indication for initiation of anticoagulation after event (e.g., known atrial fibrillation)
  2. * History of allogeneic bone marrow transplant
  3. * History of liver transplant
  4. * Subject who is unable to consent and does not have a surrogate available to consent on their behalf

Contacts and Locations

Study Contact

Andrew Weko, MPH
CONTACT
434-297-6777
crx3qp@uvahealth.org
Rachael M Stone, PharmD
CONTACT
zny6vz@uvahealth.org

Principal Investigator

Rachael M Stone, PharmD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Rachael M Stone, PharmD, PRINCIPAL_INVESTIGATOR, University of Virginia

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 Registration Dates

Study Start Date2024-04-16
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-04-16
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Ischemic Stroke
  • CYP2C19 Polymorphism