Acute ischemic stroke
Conditions
Interventions
Best Medical Treatment Group:the best medical treatment recommended in the guidelines
Dexamethasone Sodium Phosphate Combined with Best Medical Treatment Group:Dexamethasone Sodium Phosphate Injection combined with the best medical treatment recommended in the 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 old, with no upper age limit; 2.Acute ischemic stroke diagnosed based on clinical symptoms or imaging findings; 3.Randomization within 24 hours of symptom onset; 4.Non-large artery occlusive stroke confirmed by CTA/MRA/DSA; 5.NIHSS score > 5 points before enrollment, or presence of disabling symptoms (such as isolated aphasia, hemiparesis, or sensory deficits); 6.No history of bleeding in the past month (excluding gastrointestinal and urinary tract bleeding); 7.Patient or family member signed informed consent form;
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage confirmed by cranial CT or MRI; 2.Pre-morbid mRS score =2; 3.Pregnant or lactating women; 4.Planned or undergone acute endovascular therapy; 5.Currently using corticosteroids before enrollment in this episode; 6.Bleeding history in the past month (gastrointestinal or urinary tract bleeding); 7.Severe renal dysfunction on chronic hemodialysis (glomerular filtration rate <30ml/min or creatinine =220µm); 8.Any disease with expected life expectancy <6 months; 9.Expected inability to complete follow-up; 10.Allergy to corticosteroids, sulfites, or contrast agents; 11.Currently participating in other clinical trials that may affect the results of this trial; 12.Jaundice and edema; 13.Systemic infectious disease; 14.Mobitz Type II second/third-degree atrioventricular block or atrial fibrillation syndrome or history thereof;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 90 days;Symptomatic intracranial hemorrhage (SICH) within 48 hours;Proportion of patients with 90-day mRS 0-1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distiburion of 90-day mRS Score;Any intracranial hemorrhage within 48 hours;Proportion of patients with 90-day mRS 0-3;Incidence of non-hemorrhagic serious adverse events (SAEs);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);Pulmonary infection during hospitalization;Incidence of non-intracranial bleeding complications (including gastrointestinal bleeding, urethral bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma, etc.).;90-day Global Outcome;90-day EQ-5D utility index score;Proportion of patients with 90-day mRS 0-2; | — |
Countries
China
Contacts
Public ContactWenjie Zi
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed