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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug Shuxuening Injection
  Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
• Other Placebo
  Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.

Primary outcome measures

• The proportion of mRS score 0 to 1 at 90 days after randomization [Time frame: At 90 days after randomization]

Secondary outcome measures (10)

• The proportion of mRS score 0 to 2 at 90 days after randomization [Time frame: At 90 days after randomization]
• The distribution of mRS scores at 90 days after randomization [Time frame: At 90 days after randomization]
• NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge [Time frame: At 14 days after randomization or on discharge]
• EQ-5D score at 90 days after randomization [Time frame: At 90 days after randomization]
• The proportion of Barthel index score ≥95 points at 90 days after randomization [Time frame: At 90 days after randomization]
• Adverse events within 90 days after randomization [Time frame: Within 90 days after randomization]
• Serious adverse events within 90 days after randomization [Time frame: Within 90 days after randomization]
• Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization [Time frame: Within 90 days after randomization]
• Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization [Time frame: Within 90 days after randomization]
• All-cause death within 90 days after randomization [Time frame: Within 90 days after randomization]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 82 centers

• Fangshan District First Hospital — Beijing
• Chongqing Nanchuan District People's Hospital — Chongqing
• Chongqing Sanbo Chang'an Hospital — Chongqing
• Chongqing Qianjiang Central Hospital — Qianjiang
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
• Heyuan People's Hospital — Heyuan
• Huazhou People's Hospital — Maoming
• Meizhou Hospital of Traditional Chinese Medicine — Meizhou
• … and 74 more centers

Publications

• Wang A, Li J, Zhang X, Xia X, Wang Y. Rationale and design of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY): A multicenter randomized trial. Brain Circ. 2025 Nov 3;12(1):1-6. doi: 10.4103/bc.bc_65_25. eCollection 2026 Jan-Mar. PMID 41815809

Identifiers

NCT: NCT06157502 · HX-A-2023045

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗