Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

Purpose

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)

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will undergo collection of buccal swabs for CYP2C19 testing and be randomized (depending on CYP2C19 strata- normal vs. loss-of-function (LOF)* CYP2C19 allele) to their assigned study medications (aspirin and clopidogrel vs aspirin and ticagrelor).
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Genetic: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)
    CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.
    Other names:
    • genotype guided antiplatelet treatment
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.
  • Genetic: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)
    CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.
    Other names:
    • genotype guided antiplatelet treatment

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Ekaterina Bakradze, MD
205-996-1658
ebakradze@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ekaterina Bakradze, MD
205-975-8569
ebakradze@uabmc.edu

Detailed Description

This is a pilot clinical trial for feasibility