Recruiting

CYP2C19 Testing

Sponsor:

University of Alabama at Birmingham

Code:

NCT06943586

Conditions

Stroke

Transient Ischemic Attack (TIA)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)

Study Details

Brief summary:

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.

Conditions

Stroke

Transient Ischemic Attack (TIA)

Study ID

NCT06943586

Start date

Apr 9, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 18-89 years of age
  • admitted to University of Alabama at Birmingham (UAB) main hospital with symptoms or signs of minor ischemic stroke, or high risk TIA
  • eligible to receive dual antiplatelet load (presented to the hospital within 66 hours of last known well)

Exclusion Criteria:

  • diagnosis of atrial fibrillation, valvular heart disease, index stroke due to known hypercoagulability (subset of other determined etiology) or large vessel disease (culprit vessel stenosis of ≥50%)
  • prescribed anticoagulation prior to stroke
  • treated with intravenous thrombolysis
  • treated with mechanical thrombectomy
  • missing NIH Stroke Scale score

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)

CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ekaterina Bakradze, MD

205-975-8569ebakradze@uabmc.edu

Nita Limdi, PharmD, PhD

205-934-4385nlimdi@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Ekaterina Bakradze, MD

205-996-1658ebakradze@uabmc.edu

Toby Gropen, MD

205-934-2401tgropen@uabmc.edu

Principal Investigator:

Ekaterina Bakradze, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Personalized medicine
  • CYP2C19
  • minor stroke
  • Transient Ischemic Attack
  • TIA

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 Alabama at Birmingham on 2026-04-23.