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

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital

Criteria

Inclusion Criteria:

• Age 18 or older;

• Diagnosed with acute ischemic stroke;

• Within 6 hours of onset;

• Have 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;

• Hepatic or renal insufficiency (hepatic insufficiency refers to the ALT or AST levels above 2 times the upper limit of normal; 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.