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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBeijing Tiantan Hospital

About this trial

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

Qualifiers

Age 18 or older;

Diagnosed with acute ischemic stroke;

Within 6 hours of onset;

Having received or plan to undergo intravenous thrombolytic therapy;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Shuxuening Injection
  • Placebo

Treatment groups

1,380 Participants
are divided into 2 treatment groups

Locations

82
Fangshan District First Hospital BeijingBeijing Municipality, China
Chongqing Nanchuan District People's Hospital ChongqingChongqing Municipality, China
Chongqing Sanbo Chang'an Hospital ChongqingChongqing Municipality, China
Chongqing Qianjiang Central Hospital QianjiangChongqing Municipality, China

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor