Status:
RECRUITING
Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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, r...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT06157502
Start Date
January 11 2024
End Date
July 31 2026
Last Update
July 24 2025
Active Locations (82)
Enter a location and click search to find clinical trials sorted by distance.
1
Fangshan District First Hospital
Beijing, Beijing Municipality, China
2
Chongqing Nanchuan District People's Hospital
Chongqing, Chongqing Municipality, China
3
Chongqing Sanbo Chang'an Hospital
Chongqing, Chongqing Municipality, China
4
Chongqing Qianjiang Central Hospital
Qianjiang, Chongqing Municipality, China