Key result
Precision antiplatelet therapy based on CYP2C19 and 11-dhTxB2 testing will be evaluated for its effect on stroke recurrence in a planned multicenter randomized controlled trial of patients with ischemic stroke or TIA.
Why the study?
Many ischemic stroke and TIA patients exhibit resistance to clopidogrel or aspirin, but the effect of precision antiplatelet medication based on CYP2C19 genotype and 11-dhTxB2 testing has not been prospectively evaluated in a large sample.
Does precision antiplatelet therapy based on CYP2C19 and 11-dhTxB2 testing reduce stroke recurrence in patients with ischemic stroke or TIA?
RCT (n=1,200)
Single-blind
1:1 ratio via electronic program of hidden random number table
Yes
Does precision antiplatelet therapy based on CYP2C19 and 11-dhTxB2 testing reduce stroke recurrence in patients with ischemic stroke or TIA?
This study protocol outlines a randomized controlled trial to evaluate whether precision antiplatelet therapy guided by CYP2C19 and 11-dhTxB2 testing improves outcomes and reduces stroke recurrence in patients with ischemic stroke or TIA.
Background: Clopidogrel and aspirin are conventional drugs for treating ischemic stroke (IS) and transient ischemic attack (TIA). However, with the increase of clinical application, many patients have shown clopidogrel resistance (CR) and/or aspirin resistance (AR). clopidogrel resistance is related with cytochrome P450-2C19 (CYP2C19) polymorphism, and aspirin resistance is related to urine concentration of 11-dehydroxetane B2. At present, the effect of precision antiplatelet medication based on the cytochrome CYP2C19 genotype test and the 11-dhTxB2 test has not been evaluated prospectively in a large sample. Methods: This is a randomized controlled trial evaluating the effects of precision antiplatelet medication based on the CYP2C19 genotype test and the 11-dhTxB2 test on IS/TIA patients over 12 months. Outcomes of interest including stroke recurrence, neurologic disabilities defined by the Modified Rankin Scale (mRS), bleeding events, other adverse events, and all-cause mortality will be assessed at the 1st, 3rd, 6th and 12th-month post-discharge. Demographics, risk factors, laboratory investigations, medications, physiological tests, and brain imaging will also be assessed. Discussion: Some stroke patients have resistance to clopidogrel or aspirin, but there is still no personalized medicine. Our study will conduct free antiplatelet resistance tests and individualized antiplatelet medication for patients in the intervention group, ultimately evaluating individualized medication effectiveness through a one-year follow-up. The research results will help to assess the impact of personalized antiplatelet drug therapy on the prognosis of stroke, thus providing a reference for precise clinical treatment. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900026492. Registered on 12 October 2019.
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Wang et al. (2020) conducted an RCT in Ischemic stroke or transient ischemic attack (TIA) (n=1,200). Precision antiplatelet therapy based on CYP2C19 genotype and 11-dhTxB2 tests vs. Standard antiplatelet medication based on guidelines (no genetic or antiplatelet testing) was evaluated on Recurrence of stroke. Precision antiplatelet therapy based on CYP2C19 and 11-dhTxB2 testing will be evaluated for its effect on stroke recurrence in a planned multicenter randomized controlled trial of patients with ischemic stroke or TIA.
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