Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06943586
Status
Recruiting
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Conditions

  • Stroke
  • Transient Ischemic Attack (TIA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy) — GENETIC
    CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.

Study Details

The purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (TIA) patients during their hospital stay.

Key Dates

Start date
Apr 9, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: CYP2C19 strata-normal
    Participants undergo buccal swab for genetic testing to determine potential medication response to standard of care (SOC) medications. Upon result, participants are randomized (1:1) to aspirin and clopidogrel vs aspirin and ticagrelor (all SOC for this stroke population). Doses are aspirin either 81mg or loading dose 325mg, clopidogrel either 75mg or loading dose 300mg, ticagrelor either 90mg or loading dose 180mg. Loading doses are given once for aspirin, clopidogrel or ticagrelor; aspirin 81mg is taken once a day for the duration of the study; clopidogrel 75mg is once a day for 21 days only, ticagrelor 90mg is twice daily for 21 days. Participants will only receive loading dose of aspirin if not already taken at home. CYP2C19 results only affect decision regarding clopidogrel and ticagrelor but not aspirin. Aspirin is not affected by CYP2C19 mutation and will be given immediately without waiting for CYP2C19 results.
  • Active Comparator: loss-of-function CYP2C19 allele
    Participants undergo buccal swab for genetic testing to determine potential medication response to standard of care (SOC) medications. Upon result, participants are randomized (1:1) to aspirin and clopidogrel vs aspirin and ticagrelor (all SOC for this stroke population). Doses are aspirin either 81mg or loading dose 325mg, clopidogrel either 75mg or loading dose 300mg, ticagrelor either 90mg or loading dose 180mg. Loading doses are given once for aspirin, clopidogrel or ticagrelor; aspirin 81mg is taken once a day for the duration of the study; clopidogrel 75mg is once a day for 21 days only, ticagrelor 90mg is twice daily for 21 days. Participants will only receive loading dose of aspirin if not already taken at home. CYP2C19 results only affect decision regarding clopidogrel and ticagrelor but not aspirin. Aspirin is not affected by CYP2C19 mutation and will be given immediately without waiting for CYP2C19 results.

Primary Outcome Measure

Stroke participant feasibility of return of CYP2C19 genetic testing results [ Time Frame: 6 hours from buccal swab collection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Ekaterina Bakradze, MD
[email protected]
205-996-1658
Toby Gropen, MD
[email protected]
205-934-2401
Ekaterina Bakradze, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Alabama at Birmingham· Birmingham, AL

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