Acute disabling non–large vessel occlusion (non-LVO) ischemic stroke within 24 hours from last known well.
Conditions
Interventions
Trial Group:Intravenous methylprednisolone sodium succinate (MPSS), 2 mg/kg once daily by drip infusion for 3 consecutive days
Control Group:Best available standard care as recommended by guidelines
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years, with no upper age limit. 2) Clinical and/or imaging diagnosis of acute ischemic stroke. 3) Randomization can be performed within 24 hours from last known well. 4) Non–large vessel occlusion ischemic stroke confirmed by CTA/MRA/DSA (no intracranial large artery occlusion). 5) Baseline NIHSS score > 5, or presence of disabling symptoms despite NIHSS <= 5 (e.g., isolated aphasia, hemianopia, or significant motor deficit affecting daily activities). 6) Written informed consent obtained from the patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1) Intracranial hemorrhage confirmed by cranial CT or MRI. 2) Pre-stroke modified Rankin Scale (mRS) score >= 2. 3) Pregnancy or lactation. 4) Planned or ongoing acute-phase endovascular treatment. 5) Current use of systemic corticosteroids for the index stroke before randomization. 6) History of active bleeding (gastrointestinal or genitourinary) within the past 1 month. 7) Chronic hemodialysis or severe renal insufficiency (eGFR 220 µmol/L). 8) Any end-stage disease with an expected life expectancy < 6 months. 9) Expected inability to complete the 90-day follow-up. 10) Known allergy to corticosteroids or iodinated contrast agents. 11) Participation in another clinical trial that may interfere with this study. 12) Presence or history of macular edema or severe systemic infection. 13) Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or other significant cardiac conduction abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 90-day mRS score 0–1 (%);Symptomatic intracranial hemorrhage (SICH) within 48 hours;All-cause mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in NIHSS score at 5-7 days post-treatment (If the time of discharge is earlier than 5-7 days, it is the time of discharge);The degree of improvement in the 90-day mRS Score;Gastrointestinal bleeding occurred 7 days after the operation;Global Outcome Score;Incidence of systemic bleeding complications;Pulmonary infection during hospitalization;90-day EQ-5D utility index score;Any intracranial hemorrhage within 48 hours;Proportion of patients with 90-day mRS score 0–2(%);Incidence of non-hemorrhagic serious adverse events (SAEs);Proportion of patients with 90-day mRS score 0–3(%); | — |
Countries
China
Contacts
Public ContactZi Wenjie
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed