Ischemic Stroke
Conditions
Interventions
Endovascular treatment plus methylprednisolone group:Endovascular treatment combined with methylprednisolone sodium succinate
Endovascular treatment plus placebo group:Endovascular treatment combined with placebo
Sponsors
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 2.Time from symptom onset to randomization within 24 hours 3.Dagnosis of acute large vessel occlusion stroke based on clinical manifestations or imaging findings 4.NIHSS score >5 points 5.White blood cell count >= 10×10^9/L on admission 6.Large vessel occlusion confirmed by CTA/MRA/DSA (computed tomography angiography/magnetic resonance angiography/digital subtraction angiography) with planned endovascular therapy 7.Written informed consent obtained from the patient or legal representative
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI) 2.Pre-stroke modified Rankin Scale (mRS) score >= 2 3.Pregnancy or lactation 4.Contraindication to iodinated contrast media 5.Hypersensitivity to methylprednisolone sodium succinate 6.Concurrent participation in other clinical trials 7.Persistent systolic blood pressure >185 mmHg or diastolic pressure >110 mmHg despite antihypertensive medication 8.Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) >1.7 9.Blood glucose 22.2 mmol/L (400 mg/dL) 10.Arterial tortuosity precluding thrombectomy device delivery to target vessel 11.History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage) 12.Chronic hemodialysis or severe renal insufficiency [glomerular filtration rate (GFR) 220 µmol/L (2.5 mg/dL)] 13.Terminal illness with life expectancy <6 months 14.Anticipated inability to complete follow-up 15.Intracranial aneurysm or arteriovenous malformation 16.Space-occupying brain tumor with mass effect on imaging 17.Macular edema 18.Mobitz type II second-/third-degree atrioventricular block or sick sinus syndrome (current or historical) 19.Active systemic infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of 90-day mRS Score;All-cause mortality at 90 days;Symptomatic intracranial hemorrhage (SICH) within 48 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with 90-day mRS 0-4 (%);Proportion of patients with 90-day mRS 0-3 (%);Proportion of patients with 90-day mRS 0-2 (%);Proportion of patients with 90-day mRS 0-1 (%);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);90-day EQ-5D utility index score;Any intracranial hemorrhage within 48 hours;Systemic bleeding complications;Non-hemorrhagic serious adverse events (SAEs);Gastrointestinal bleeding within 7 days post-procedure;Pulmonary infection during hospitalization; | — |
Countries
China
Contacts
Public ContactWenjie Zi
Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed