Rationale and design of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY): A multicenter randomized trial.

Abstract

Background: Shuxuening injection (SXNI), a multi-target cerebroprotectant, holds promise as adjuvant therapy to intravenous thrombolysis (IVT) in acute ischemic stroke (AIS), but its efficacy has not yet been established.

Aim: The aim of this study was to present the rationale and design of the Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY) trial.

Design: This multicenter, randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of SXNI in AIS patients undergoing IVT. The estimated sample size is 1380 patients. Eligible participants aged ≥ 18 years with symptom onset within 6 h, who are receiving or planned for IVT and have a baseline National Institutes of Health Stroke Scale score of 4-25, will be randomly assigned (1:1) to receive either SXNI or placebo for 10-14 days.

Study outcomes: The primary efficacy outcome is the proportion of patients with favorable functional outcome (modified Rankin Scale score of 0-1) at 90 days. The primary safety outcome is the adverse events within 90 days.

Discussion: The SHINY trial will provide evidence on whether SXNI exerts cerebroprotective effect in IVT-treated AIS patients.

Trial registration: ClinicalTrials.gov (identifier: NCT06157502).