Acute Ischemic Stroke with Large Vessel Occlusion
Conditions
Interventions
Methylprednisolone Sodium Succinate Group:intravenous injection, 2 mg/kg, once daily for three consecutive days, with the first dose administered before the procedure. Endovascular interventions inclu
Glimepiride Group:1 mg per dose, once daily for three consecutive days, administered orally or through nasogastric tube feeding. Endovascular interventions include mechanical thrombectomy, contact asp
Methylprednisolone Sodium Succinate plus Glimepiride Group:Methylprednisolone sodium succinate: intravenous injection, 2 mg/kg, once daily for three consecutive days, with the first dose administered
Glimepiride: 1 mg once daily for three consecutive days, administered orally or via nasogastric tube. Endovascular interventions include mechanical thrombectomy, contact aspiration, intra-arterial thr
Control Group:Study participants receive endovascular treatment. Endovascular interventions include mechanical thrombectomy, contact aspiration, intra-arterial thrombolysis, balloon angioplasty, and/o
Sponsors
Lanzhou University Second Hospital
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. Preliminary diagnosis of large vessel occlusion stroke based on clinical symptoms or imaging examination; 4. NIHSS score >5; 5. ASPECTS <=6; 6. Large vessel occlusion confirmed by CTA/MRA/DSA with decision for endovascular treatment; 7. Written informed consent signed by the patient or family members.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2. Pre-stroke mRS score =2; 3. Pregnant or lactating women; 4. Allergy to contrast agents; 5. Allergy to corticosteroids; 6. Allergy to glimepiride; 7. Type 1 diabetes mellitus; 8. Severe hepatic insufficiency; 9. Currently participating in other clinical trials; 10. Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, uncontrollable with oral antihypertensive medications; 11. Hereditary or acquired bleeding diathesis, coagulation factor deficiency; or taking oral anticoagulants with INR >1.7; 12. Blood glucose 22.2 mmol/L (400 mg/dl); 13. Oral administration of glimepiride within 10 hours before stroke onset; 14. History of diabetic ketoacidosis or diabetic coma/pre-coma; 15. Arterial tortuosity preventing thrombectomy device from reaching target vessel; 16. Bleeding history within the past month (gastrointestinal and urinary tract bleeding); 17. Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220 µmol/L (2.5 mg/dl)); 18. End-stage disease with life expectancy <6 months; 19. Expected inability to complete follow-up; 20. Intracranial aneurysm or arteriovenous malformation; 21. Brain tumor with mass effect on imaging; 22. Macular edema; 23. Systemic infectious disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mRS score 0-4 (%);90-day mortality (%);Incidence of symptomatic intracranial hemorrhage within 48 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day mRS score 0-1 (%);90-day mRS score 0-2 (%);90-day mRS score 0-3 (%);Improvement in mRS score at 90 days (shift analysis);Change in NIHSS Score at 5-7 days after treatment (or at discharge if earlier than 5-7 days);Brain midline shift at 72-96 hours;EQ-5D score at 90 days;Incidence of any intracranial hemorrhage within 48 hours after treatment;Incidence of systemic bleeding complications;Incidence of non-bleeding serious adverse events;Gastrointestinal bleeding within 7 days after procedure;Pulmonary infection during hospitalization;Incidence of hypoglycemia after medication administration (%);Incidence of hyperglycemia after medication administration (%); | — |
Countries
China
Contacts
Public ContactZhenchang Zhang
Lanzhou University Second Hospital
Outcome results
None listed