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

StatusRecruiting
PhasePhase 3
Started2024-01-11
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 24, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-21
Study Status v4
Primary completion date2025-06-01→2025-12-31
Completion date2026-12-01→2026-07-31
2024-08-22
Study Status, Eligibility, Contacts/Locations v3
Study sites30→82
Eligibility criteria+23 characters
Inclusion Criteria: Age 18 or older; Diagnosed with acute ischemic stroke; Within 6 hours of onset; HaveHaving received or plan to undergo intravenous thrombolytic therap [...] rders, systemic bleeding, thrombocytopenia, or neutropenia; HepaticSevere hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 23 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 [...]
2024-02-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-01→confirmed 2024-01-11
Study sites0→30
2023-12-12
Study Status, Study Description, Outcome Measures v1
Primary completion date2025-12-01→2025-06-01
Start date2023-12-01→2024-01-01
Secondary endpointsdetails revised at 5 of 10 entries
Study description-15 characters
[...] andomized, double-blind, placebo-parallel controlled trial. We plan to recruit 50 centers in China. A total of 1380 patients from 50 centers in China who could be treated within 6 hours of onset and have recei [...]
2023-11-27
Original filing
Beijing Tiantan Hospital
280 trials monitored
See 4 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
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.
Trial Details
NCT Number NCT06157502
Lead Sponsor Beijing Tiantan Hospital
Conditions Ischemic Stroke, Acute
Enrollment 1,380 participants
Start Date 2024-01-11
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-24