Stroke, Transient Ischemic Attack (TIA)
Conditions
Keywords
Personalized medicine, CYP2C19, minor stroke, Transient Ischemic Attack, TIA
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
Interventions
GENETICCYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)
CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTEkaterina Bakradze, MD
CONTACTNita Limdi, PharmD, PhD
PRINCIPAL_INVESTIGATOREkaterina Bakradze, MD
University of Alabama at Birmingham
Outcome results
None listed