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

Phase 3

Recruiting

• Conditions: Ischemic Stroke, Acute

• Registration Number: NCT06157502
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1380

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18 or older;<br><br> - Diagnosed with acute ischemic stroke;<br><br> - Within 6 hours of onset;<br><br> - Having received or plan to undergo intravenous thrombolytic therapy;<br><br> - NIHISS score of 4 to 25 points at enrollment;<br><br> - Signed informed consent.<br><br>Exclusion Criteria:<br><br> - mRS score greater than 1 point before the onset;<br><br> - Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol,<br> butylphthalein, etc. after the onset;<br><br> - Bleeding or other pathological brain disorders, such as vascular malformations,<br> tumors, abscesses, or other common non-ischemic brain diseases (such as multiple<br> sclerosis), detected by CT/MRI;<br><br> - History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;<br><br> - Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the<br> ALT or AST levels above 3 times the upper limit of normal; severe renal<br> insufficiency refers to the creatinine levels above 2 times the upper limit of<br> normal);<br><br> - Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo<br> biloba extract);<br><br> - Women who are pregnant or breastfeeding, and women of childbearing age who have a<br> negative pregnancy test but refuse to take effective contraceptive measures;<br><br> - Participation in another clinical trial with an experimental product during the last<br> 30 days;<br><br> - Other participants deemed unsuitable for participation in this study by the<br> investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of mRS score 0 to 1 at 90 days after randomization

Secondary Outcome Measures

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