Clinical trial NCT06943586: Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing
Official title: Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing in Patients With Minor Stroke or High Risk TIA (CYP2C19 and Stroke)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Transient Ischemic Attack (TIA)
Keywords: Personalized medicine
CYP2C19
minor stroke
Transient Ischemic Attack
TIA
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Stroke participant feasibility of return of CYP2C19 genetic testing results
timeFrame: 6 hours from buccal swab collection
Secondary outcomes:
measure: Recurrent stroke, TIA, major bleeding and Modified Rankin Scale at ~90days
timeFrame: 90 days following stroke
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ekaterina Bakradze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordeen JD, Patel AV, Darracott RM, Johns GS, Taussky P, Tawk RG, Miller DA, Freeman WD, Hanel RA. Clopidogrel Resistance by P2Y12 Platelet Function Testing in Patients Undergoing Neuroendovascular Procedures: Incidence of Ischemic and Hemorrhagic Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34.
citation: Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.
citation: Wang Y, Meng X, Wang A, Xie X, Pan Y, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Niu S, Wang Y, Zhao X, Li Z, Jiang Y, Li W, Liu L, Xu J, Chang L, Wang L, Zhuang X, Zhao J, Feng Y, Man H, Li G, Wang B; CHANCE-2 Investigators. Ticagrelor versus Clopidogrel in CYP2C19 Loss-of-Function Carriers with Stroke or TIA. N Engl J Med. 2021 Dec 30;385(27):2520-2530. doi: 10.1056/NEJMoa2111749. Epub 2021 Oct 28.
citation: Pereira NL, Cresci S, Angiolillo DJ, Batchelor W, Capers Q 4th, Cavallari LH, Leifer D, Luzum JA, Roden DM, Stellos K, Turrise SL, Tuteja S; American Heart Association Professional/Public Education and Publications Committee of the Council on Genomic and Precision Medicine; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Peripheral Vascular Disease; and Stroke Council. CYP2C19 Genetic Testing for Oral P2Y12 Inhibitor Therapy: A Scientific Statement From the American Heart Association. Circulation. 2024 Aug 6;150(6):e129-e150. doi: 10.1161/CIR.0000000000001257. Epub 2024 Jun 20.
citation: Prevention: Cfdca. Centers for disease control and prevention: Stroke. Accessed May 18, 2023