NCT06157502 Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
| NCT ID | NCT06157502 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Ischemic Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,380 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,380 participants in total. It began in 2024-01-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06157502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Ischemic Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06157502 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,380 participants.
Is NCT06157502 currently recruiting?
Yes, NCT06157502 is actively recruiting participants. Contact the research team at anxin0907@163.com for enrollment information.
Where is the NCT06157502 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Chongqing, China, Qianjiang, China and 11 additional locations.
Who is sponsoring the NCT06157502 clinical trial?
NCT06157502 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 1,380 participants.
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