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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06157502

Collaborator

(none)

1,380

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke, Acute	Drug: Shuxuening Injection Other: Placebo	Phase 3

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. We plan to recruit 50 centers in China. A total of 1380 patients 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shuxuening injection Shuxuening Injection + Intravenous Thrombolysis	Drug: Shuxuening Injection Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Placebo Comparator: Placebo Placebo + Intravenous Thrombolysis	Other: Placebo Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.

Arm

Intervention/Treatment

Experimental: Shuxuening injection

Shuxuening Injection + Intravenous Thrombolysis

Drug: Shuxuening Injection

Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days

Placebo Comparator: Placebo

Placebo + Intravenous Thrombolysis

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.