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

Launched by BEIJING TIANTAN HOSPITAL · Nov 27, 2023

Keywords

ClinConnect Summary

The SHINY trial is studying a treatment called Shuxuening injection for patients who have had an acute ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels supplying the brain. The goal is to see if Shuxuening can help protect the brain when given alongside a standard treatment called intravenous thrombolysis, which aims to dissolve the blood clot causing the stroke. This trial is looking for participants aged 18 and older who have experienced a stroke within the past 6 hours and are currently receiving or will receive thrombolytic therapy. Participants will need to provide consent and have a specific score on a stroke severity scale to qualify.

If you join this trial, you'll be randomly assigned to receive either the Shuxuening injection or a placebo (a substance with no active treatment) while continuing your usual care. The study is currently recruiting participants and aims to assess both the safety and effectiveness of Shuxuening. It's important to note that certain health conditions or treatments may prevent you from participating, such as having a recent history of severe bleeding or certain brain disorders. If you're interested, please discuss this opportunity with your healthcare provider to see if you may be eligible.

Gender

ALL

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.