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NCT Number: NCT06943586

Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

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.

Recruiting

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Transient Ischemic Attack (TIA) Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a pilot clinical trial for feasibility

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: genotype guided antiplatelet treatment

Primary outcomes

  1. Stroke participant feasibility of return of CYP2C19 genetic testing results

    Time frame: 6 hours from buccal swab collection

    This outcome is to determine the feasibility of receiving CYP2C19 genetic testing results (strata-normal vs. loss-of-function allele) on minor ischemic stroke and high risk TIA inpatients within a 6-hour window to determine drug metabolization for antiplatelet effect to guide standard of care treatment. Inpatients that have been admitted to the hospital, within 66 hours of last known well time, will have buccal swabs collected during hospitalization for the CYP2C19 genetic testing. Results must be received within 6 hours to effectively randomize subjects.

Secondary outcomes

  1. Recurrent stroke, TIA, major bleeding and Modified Rankin Scale at ~90days

    Time frame: 90 days following stroke

    Participants will undergo a visit approximately 90 days following stroke to assess for any new stroke like symptoms and recovery in daily activities via the modified Rankin scale (mRS) Score. The mRS is a widely used tool to assess functional outcome after a stroke or other neurological events, ranging from 0 (no symptoms) to 6 (dead), with higher scores indicating greater disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Ekaterina Bakradze, MD

CONTACT

[email protected]

205-975-8569

Nita Limdi, PharmD, PhD

CONTACT

[email protected]

205-934-4385

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing in Patients With Minor Stroke or High Risk TIA (CYP2C19 and Stroke)

Acronym: CYP-FAST

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 24, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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