Ischemic Stroke
Conditions
Interventions
methylprednisolone group:Methylprednisolone + Sodium Succinate Standard Treatment
Standard medical treatment group:Standard medical treatment
Sponsors
The Second Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, with no upper age limit; 2.Preliminary diagnosis of acute ischemic stroke based on clinical symptoms and/or imaging findings; 3.Within 24 hours from symptom onset to randomization; 4.Non-large-vessel-occlusion stroke confirmed by CTA, MRA, or DSA; 5.NIHSS score >5 before enrollment, or presence of disabling symptoms (e.g., isolated aphasia, hemianopia, or limb weakness affecting function); 6.Written informed consent provided by the patient or a legally authorized representative.
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage confirmed by cranial CT or MRI; 2.Pre-stroke mRS score>=2; 3.Pregnant or breastfeeding women; 4.Planned acute-phase endovascular treatment or prior receipt of acute-phase endovascular treatment; 5.Use of glucocorticoids before enrollment for the current stroke event; 6.History of bleeding within the past 1 month (including gastrointestinal or urinary tract bleeding); 7.Patients on chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate 220 µmol/L); 8.Advanced-stage disease of any kind with an expected survival of <6 months; 9.Expected inability to complete follow-up; 10.Allergy to glucocorticoids or contrast agents; 11.Current participation in another clinical trial that may affect the results of this study; 12.Macular edema; 13.Systemic infectious disease; 14.Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or a history of these conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of 90-day mRS Scores 0-1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Outcome Score;Changes of 90-day mRS Score;The proportion of 90-day mRS Scores 0-2;The proportion of 90-day mRS Scores 0-3;Changes of NIHSS score 5-7 days after treatment;90-day EQ-5D scale score;90-day mortality;Proportion of symptomatic intracranial hemorrhage within 48 hours;Incidence of any intracranial hemorrhage within 48 hours;Incidence of systemic bleeding complications;Incidence of non-hemorrhagic serious adverse events;Gastrointestinal bleeding within 7 days after treatment;In-hospital pulmonary infection; | — |
Countries
China
Contacts
Public ContactWenjie Zi
The Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed