Acute ischemic stroke.
Conditions
Interventions
Control Group:Administration of a sivelestat sodium placebo by intravenous infusion
Experimental group.:Sivelastan sodium for Injetion
Sponsors
The Peopie's Hospital of Gaomi
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old. 2. mRS <= 1 points prior to onset of symptoms. 3. It manifests as an acute, disabling ischemic stroke, affecting the anterior or posterior circulation, with or without visible occlusion. 4. The onset of the disease occurred within 24 hours, including patients with post-awakening strokes or strokes without witnesses; the onset time was defined as the last known normal time (LKW). 5. Receiving intravenous thrombolysis treatment. 6. The National Institutes of Health Stroke Scale (NIHSS) was 4-25 points prior to intravenous thrombolysis. 7. The patient or their legal representative signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled for endovascular therapy (EVT). 2. Non-enhanced computed tomography (NCCT) or diffusion-weighted magnetic resonance imaging (DWI-MRI) shows an ASPECTS or pc-ASPECTS score of 185 mmHg or diastolic pressure > 110 mmHg, and uncontrolled by antihypertensive medications. 6. Glucose level 400 mg/dL (22.2 mmol/L). 7. Platelet count 1.7. 9. Severe renal failure, defined as serum creatinine > 3.0 mg/dL (265.2 µmol/L) or glomerular filtration rate (GFR) < 30 mL/min, or requiring hemodialysis or peritoneal dialysis. 10. Suspected aortic dissection; 11. Suspected vasculitis or septic embolism; 12. Patients unable to complete the 90-day follow-up (e.g., no fixed address, overseas patients, etc.); 13. Pre-existing neurological disorders or mental illnesses prior to onset that may affect the assessment of the condition; 14. Pregnant or breastfeeding women; 15. Patients diagnosed with rheumatic or autoimmune diseases on long-term use of immunosuppressants or corticosteroids; 16. Patients currently receiving chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, Ulinastatin, etc.); 17. Current participation in other clinical trials that may interfere with the results of this study; 18. Other conditions deemed by the investigator to make the patient unsuitable for participation or that may pose a significant risk to the patient; 19. Sedated and intubated patients did not have baseline NIHSS data. 20. A seizure episode at the time of death impeded the collection of baseline NIHSS data. 21. Double-sided dilated pupils.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 90-day mRS score 0-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in NIHSS score at day 7 or discharge;Incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours, as defined by the Heidelberg criteria;Change in NIHSS score at 48 hours;Proportion of patients with early neurological improvement, defined as a reduction in NIHSS score of >=4 points from baseline or an NIHSS score <=1 at 48 hours;Incidence of intracranial hemorrhage (ICH) within the 48 hours after enrollment;Proportion of patients with 90-day mRS score 0-3;EuroQol Five-Dimensional (EQ-5D) scale score at 90 days;Shift analysis of the full range of 90-day mRS scores;Incidence of serious adverse events (SAEs);Proportion of patients with 90-day mRS score 0-1;Barthel Index assessment at 90 days post-enrollment;Mortality within 90 days after enrollment; | — |
Countries
China
Contacts
Public ContactShaoguang Wu
The Peopie's Hospital of Gaomi
Outcome results
None listed