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
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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with mRS ≤1 on day 90 | day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Changes of NIHSS score from baseline on day 14 | day 14 |
| The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 | day 14, 30, 90 |
| mRS score on day 90 | day 90 |
| Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | day 14, 30, 90 |
| Stroke Impact Scale (SIS) score on day 90 | day 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 |
Countries
China
Outcome results
None listed