Acute Ischemic Stroke
Conditions
Brief summary
The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.
Interventions
DRUGCompound Edaravone Injection-Low dose
Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
DRUGCompound Edaravone Injection-High dose
Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
DRUGPlacebo injection
Placebo injection, one dose every 12 hours, continue for 14 days
Sponsors
Nanjing Yoko Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 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 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; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min; * Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; * Thrombectomy or interventional therapy has been applied or planned after this onset; * Patients with malignant tumors or receiving concurrent antitumor treatment; * Patients with severe systemic disease, life expectancy is less than 90 days; * Allergic to edaravone , taurine or related excipients; * Pregnant or lactating women; * Have major surgery within 4 weeks before enrollment and not recovered enough to start the study; * Participated 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 |
|---|---|
| The proportion of patients with mRS ≤1 on day 90 | day 90 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with mRS ≤2 on day 90 | day 90 |
| The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 | day 14, 30, 90 |
| Changes of NIHSS score from baseline on day 14 | day 14 |
| EQ-5D score on day 90 | day 90 |
| Ordinal Distribution of mRS on day 90 | day 90 |
| The proportion of patients with ADL-BI ≥95 on day 14, 30, 90 | day 14, 30, 90 |
Countries
China
Outcome results
None listed