To study the mechanism of panax notoginseng in the treatment of aspirin resistance in the secondary prevention of stroke based on TLR4/MyD88/NF-κB signaling pathway: A study protocol

Aspirin, as an typical antiplatelet therapy for secondary stroke prevention, have been proved that can significantly reduce incidence and recurrence of cerebrovascular ischemic events. However, due to drugs biological characteristics, aspirin resistance (AR) often occurs in clinical practice, which significantly influence secondary prevention in stroke patients. The growing evidence of activating blood and removing stasis herbs medicine (Sanqi) for AR is promising. However, the efficacy and mechanism of Panax notoginseng (Sanqi) for AR in secondary stroke prevention has not been confirmed. METHODS/DESIGN: This is a prospective 2-center, assessor and statistician blinded, randomized, controlled trial. We will allocate 106 subjects aged between 45 and 65 years old, diagnosed with aspirin semi-resistance after stroke to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with conventional treatments plus Panax notoginseng (Sanqi) while the others in the control group will be treated with only conventional treatments. All will be given different medications for 30 days. Patients will be measured with the platelet aggregation rate and serum TLR4, MyD88, NF-κB, COX-2, IL-6, CRP, TXB2 level for clinical efficacy and mechanisms at baseline and the 14(th), 30(th) day of treatment. Baseline characteristics of patients will be summarized by groups and compared with Chi-square for categorical variables, and Student’s independent t test or nonparametric Mann-Whitney U test for the continuous variables. Primary and secondary outcomes will be analyzed with 2-way repeated measures Anova, and Post Hoc test. CONCLUSION: The present study aims to investigate short-term add-on efficacy and mechanism of Panax notoginseng (Sanqi) for aspirin resistance in secondary stroke prevention via TLR4/MyD88/NF-κB signaling pathway. With this, we expect to find out an appropriate partial substitute of aspirin for aspirin resistance individuals. TRIAL REGISTRATION: The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR2100045773 at April 24, 2021.