Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)
GeneticCYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: CYP2C19 strata-normalActive comparator 1 intervention
Group B: loss-of-function CYP2C19 alleleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stroke participant feasibility of return of CYP2C19 genetic testing results
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.
Time frame
6 hours from buccal swab collectionSecondary outcomes
1
Recurrent stroke, TIA, major bleeding and Modified Rankin Scale at ~90days
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.
Time frame
90 days following strokeSponsors and contacts
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Source ClinicalTrials.gov