Acute Ischemic Stroke
Conditions
Brief 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.
Interventions
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score on day 90 | day 90 |
| Change from baseline NIHSS score on day 14 | day 14 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 | day 14, 30, 90 |
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 | day 14, 30, 90 |
| The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | day 14, 30, 90 |
| Stroke Impact Scale (SIS) score on day 90 | day 90 |
Countries
China
Outcome results
None listed