Compound Edaravone Injection for Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;

2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Antipyrine; Edaravone; Phenylmethylpyrazolone

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.