Study of Shuxuening Injection Combined With Intravenous Thrombolysis for Treating Acute Ischemic Stroke in Adults

What this Trial Is About

Researchers are evaluating Shuxuening injection, a multi-target neuroprotective agent, to see its effects when added to intravenous thrombolysis therapy in patients with acute ischemic stroke. This large, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of Shuxuening injection in improving outcomes after stroke. Intravenous thrombolysis with rt-PA is the current standard treatment, but many patients still experience significant disability, so neuroprotective agents like Shuxuening may help reduce brain cell death. Participants will be randomly assigned to one of two groups one group will receive Shuxuening injection combined with intravenous thrombolysis, and the other will receive a placebo combined with intravenous thrombolysis. Both treatments involve a daily intravenous drip of 20 ml Shuxuening or placebo plus 250 ml of 0.9% sodium chloride for 10 to 14 days. The study plans to enroll 1380 patients within 6 hours of stroke onset from 50 centers across China. During the study, participants will be monitored closely with assessments including the modified Rankin Scale mRS score at 90 days to measure functional recovery, along with safety monitoring for adverse events over 90 days. Other evaluations include neurological function scores, quality of life surveys, and various safety outcomes. The trial will last for at least 90 days after treatment, with data collected on disability, recovery, and any side effects experienced.

Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)