shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke (shiny)

Conditions: Ischemic Stroke, Acute

Summary: shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. the primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.

intravenous thrombolysis with rt-pa within the time window is the most effective drug for acute ischemic stroke, but there are still more than 50% patients with functional disability. neuroprotective agents can reduce brain cell death after cerebral ischemia by blocking all links of ischemic cascade. shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. this study is a multicenter, randomized, double-blind, placebo-parallel controlled trial. a total of 1380 patients from 50 centers in china who could be treated within 6 hours of onset and have received or plan to undergo intravenous thrombolytic therapy will be enrolled and randomly assigned, in a 1:1 ratio, to receive shuxuening injection (20 ml shuxuening injection + 250 ml 0.9% sodium chloride injection), or to receive shuxuening injection placebo (20 ml plus 250 ml 0.9% sodium chloride injection); both groups are treated for 10-14 days. the primary efficacy outcome is mrs score 0 to 1 at 90 days, and the primary safety outcome is adverse events within 90 days.

Eligibility criteria:
inclusion criteria: * age 18 or older; * diagnosed with acute ischemic stroke; * within 6 hours of onset; * having received or plan to undergo intravenous thrombolytic therapy; * nihiss score of 4 to 25 points at enrollment; * signed informed consent. exclusion criteria: * mrs score greater than 1 point before the onset; * receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset; * bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by ct/mri; * history of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia; * severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the alt or ast levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal); * allergic to shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract); * women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures; * participation in another clinical trial with an experimental product during the last 30 days; * other participants deemed unsuitable for participation in this study by the investigator.

Keywords: ischemic stroke intravenous thrombolysis neuroprotective therapy shuxuening injection randomized controlled trial