ArticleBrain circulation
Rationale and design of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY): A multicenter randomized trial.
Article in Brain circulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06157502 (Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
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Authors and funding
5 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundShuxuening 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.
aimThe 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.
designThis 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 registrationClinicalTrials.gov (identifier: NCT06157502).
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