Compound Edaravone Injection for Acute Ischemic Stroke


Phase 2 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 to 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;
- Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
- Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Arterial or venous thrombolytic therapy has been applied after onset;
- With malignant tumors or receiving concurrent antitumor treatment;
- With severe systemic disease, life expectancy is less than 90 days;
- Pregnant or lactating women;
- Participate in other clinical studies within 30 days before randomization;
- The investigators consider the patients are not suitable for this trial.