Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

Not Applicable

Recruiting

• Conditions: Stroke; Transient Ischemic Attack (TIA)

• Registration Number: NCT06943586
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

This is a pilot clinical trial for feasibility

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study Start: 2025-04-09
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Primary Completion: 2028-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stroke participant feasibility of return of CYP2C19 genetic testing results	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 Outcome Measures

Name	Time	Method
Recurrent stroke, TIA, major bleeding and Modified Rankin Scale at ~90days	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States