Acute Ischemic Stroke
Conditions
Interventions
Treatment group:Edaravone and Dexborneol Concentrated Solution for Injection
Control group:Placebo
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients, aged 35-80 years; 2. Clinically diagnosed of ischemic stroke; 3. Onset of stroke is less than or equal to 48 hours; 4. Imaging diagnosed of moderate cerebral infarction with diameter 3-5cm; 5. Patients or legally authorized representatives signed written inform consent.
Exclusion criteria
Exclusion criteria: 1. Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; 2. Iatrogenic stroke; 3. Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1; 4. mRS score prior to this onset is greater than 1; 5. Transient ischemic attack (TIA); 6. SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg; 7. Severe mental disorders and dementia; 8. ALT or AST is greater than 2.0 x ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis; Serum Creatinine (SCr) is greater than 1.5 x ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases and renal insufficiency; 9. Patients with severe autoimmune diseases; 10. Patients with severe heart diseases, myocardial infarction complicated by mitral insufficiency; 11. Previous diabetes poorly controlled; 12. Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase and some Chinese patent medicines containing (+)-Borneol were also not allowed; 13. Arterial or venous thrombolytic therapy has been applied after onset of stroke; 14. Intravascular mechanical thrombectomy has been or is to be applied after stroke onset; 15. Patients with malignant tumors or receiving concurrent antitumor treatment; 16. Severe systemic disease, life expectancy is less than 90 days; 17. Allergic to edaravone, (+)-Borneol or related excipients; 18. Pregnant or lactating women; 19. Major surgery within 4 weeks before enrollment; 20. Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; 21. Patients taking antitumor or immunomodulatory drugs; 22. Patients contraindicated to MRI or PET scan, including but not limited to claustrophobia and metal prosthesis; 23. Investigators consider the patients are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microglia activation at d14, d90; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score; | — |
Countries
China
Contacts
Public ContactShi Fudong
Tianjin Medical University General Hospital
Outcome results
None listed