Ischemic Stroke Clinical Trial
— ORCA-AISOfficial title:
Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke
NCT number | NCT06292117 |
Other study ID # | 230247 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 16, 2024 |
Est. completion date | June 2026 |
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptability of deferred consent process in participants approached for full informed consent | Structured interview and/or written survey with pre-specified questions | At time of 90-day follow-up | |
Other | Cost-effectiveness of CYP2C19-guided dual antiplatelet therapy after acute ischemic stroke | Cost-effectiveness analysis reporting incremental cost-effectiveness ratios (ICER) | From time of participant blood draw up to 90 days after | |
Primary | 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 | At time of participant discharge from hospital; approximately 1-5 days | ||
Primary | Average turnaround time of genotype result from time of collection of blood sample to time result is entered into the electronic health record | From time of participant blood draw up to 21 days after | ||
Secondary | Number of CYP2C19 LOF carriers for whom a genotype-guided modification to DAPT is made | Within 30 days of participant index event | ||
Secondary | Number needed to genotype (NNG): number of patients who would need to undergo genotyping to have a recommended change in DAPT based on genotype | Within 30 days of participant index event | ||
Secondary | Stroke-free status via the Questionnaire to Verify Stroke-Free Status (QVSFS) of participants at 90 days in participants who received DAPT | 90 days after participant index event | ||
Secondary | Major adverse cardiovascular events at 90 days in participants who received DAPT | 90 days after participant index event | ||
Secondary | Correlation between P2Y12 reaction units (PRUs) measured via P2Y12 assay and CYP2C19 genotype in patients who received DAPT | P2Y12 assay collected at least 12 hours after loading dose of P2Y12 inhibitor OR after three doses of maintenance dose if did not receive loading dose | During participant admission, approximately 1-3 days |
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