Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Active, not recruiting

Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Hospitalized patients, diagnosed of ischemic stroke;
- Onset of stroke is less than or equal to 48 hours;
- There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
- Patients signed written inform consent

Exclusion Criteria

- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Iatrogenic stroke;
- Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1;
- The mRS score prior to this onset is greater than 1;
- Transient ischemic attack (TIA);
- 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;
- Patients with severe mental disorders and dementia;
- ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
- Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
- Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Arterial or venous thrombolytic therapy has been applied after onset of stroke;
- Patients with malignant tumors or receiving concurrent antitumor treatment;
- Patients with severe systemic disease, life expectancy is less than 90 days;
- allergic to edaravone , (+)-Borneol or related excipients;
- Pregnant or lactating women;
- Have major surgery within 4 weeks before enrollment;
- Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
- The investigators consider the patients are not suitable for this trial.