Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Stroke; Transient Ischemic Attack (TIA)

Treatments: Genetic: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06943586

MULTIPI8165 (Other Grant/Funding Number)

IRB-300013920

Details and patient eligibility

About

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.

Full description

This is a pilot clinical trial for feasibility

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

CYP2C19 strata-normal

Active Comparator group

Description:

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.

Treatment:

Genetic: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)

loss-of-function CYP2C19 allele

Active Comparator group

Description:

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.

Treatment:

Genetic: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)