Effects of precision antiplatelet therapy based on CYP2C19/11-dhTxB2 variability in prognosis of ischemic stroke/TIA patients: study protocol for a multicenter randomized controlled trial

Abstract

IntroductionClopidogrel and aspirin are routine drugs for the treatment of ischemic stroke (IS) and transient ischemic attack (TIA). However, with the increase of clinical application, a large number of patients have displayed clopidogrel resistance and/or aspirin resistance. At present, the effect of genetically tailored medication has not been prospective evaluated in a large sample.Methods and analysisThis study is an investigator-initiated, multicentre, large sample, prospectively, randomized controlled study evaluating the effects of precision antiplatelet medication based on the cytochrome P450 2C19 (CYP2C19) genetic test and the 11-dehydroxetane B2 (11-dhTxB2) test on IS/TIA patients over a duration of 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 be assessed as well.Ethics and disseminationThe study was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Nanchang University: (2018) Medical Research Review No.05. In this study, a pre-experiment was carried out in April 2019. Formal recruitment of patients began in June 2019 and will continue until December 2020. Participants will be followed for one-year and the study will end in December 2021. The results of the study will be disseminated through peer-reviewed publications and conference reports.Trial registration numberChiCTR1900026492.Trial registration date2019.10.12Trial registry name“Establishment of intelligent decision-making system for treatment of neurological impairment in cerebrovascular disease”. Tt is a prospectively study.Protocol versionV5.0, 2019/02/19.