Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.
The main questions this study aims to answer are:
* What are the best strategies to implement this genetic test in the hospital? * Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?
Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women at least 18 years of age
Presenting with symptoms of acute ischemic stroke or transient ischemic attack and without contraindications to dual antiplatelet therapy at time of clinical research coordinator screening
Presenting within 24 of symptom onset; or, within 24-96 hours of symptom onset IF planned to receive or already on dual antiplatelet therapy
Disqualifiers
Receiving therapeutic anticoagulation or clear indication for initiation of anticoagulation after event (e.g., known atrial fibrillation)
History of allogeneic bone marrow transplant
History of liver transplant
Subject who is unable to consent and does not have a surrogate available to consent on their behalf
Trial population
Individuals evaluated in the Emergency Department or admitted inpatient at an academic medical center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CYP2C19 Genotype
Other interventionqPCR-based genotyping assay interrogating all Association for Molecular Pathology (AMP) recommended Tier 1 and Tier 2 single nucleotide polymorphisms (SNPs) for CYP2C19 (\*2, \*3, \*4, \*5, \*6, \*7, \*8, \*9, \*10, \*17, \*35)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Percentage of patients discharged from University of Virginia (UVA) Health on dual antiplatelet therapy with a diagnosis of AIS/TIA meeting eligibility criteria upon presentation that are successfully genotyped
Time frame
At time of participant discharge from hospital; approximately 1-5 days2
Average turnaround time of genotype result from time of collection of blood sample to time result is entered into the electronic health record
Time frame
From time of participant blood draw up to 21 days afterSecondary outcomes
1
Number of CYP2C19 LOF carriers for whom a genotype-guided modification to DAPT is made
Time frame
Within 30 days of participant index event2
Number needed to genotype (NNG): number of patients who would need to undergo genotyping to have a recommended change in DAPT based on genotype
Time frame
Within 30 days of participant index event3
Stroke-free status via the Questionnaire to Verify Stroke-Free Status (QVSFS) of participants at 90 days in participants who received DAPT
Time frame
90 days after participant index event4
Major adverse cardiovascular events at 90 days in participants who received DAPT
Time frame
90 days after participant index eventOther outcomes
1
Acceptability of deferred consent process in participants approached for full informed consent
Structured interview and/or written survey with pre-specified questions
Time frame
At time of 90-day follow-up2
Cost-effectiveness of CYP2C19-guided dual antiplatelet therapy after acute ischemic stroke
Cost-effectiveness analysis reporting incremental cost-effectiveness ratios (ICER)
Time frame
From time of participant blood draw up to 90 days afterSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov