NCT02430350已完成3 期
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 48
- 主要终点
- The proportion of patients with mRS ≤1 on day 90
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Compound Edaravone
Experimental
Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
干预措施: Compound Edaravone Injection (Drug)
Edaravone
Active Comparator
Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
干预措施: Edaravone Injection (Drug)
结局指标
主要结局
The proportion of patients with mRS ≤1 on day 90
时间窗: day 90
次要结局
- The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90(day 14, 30, 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)
- Changes of NIHSS score from baseline on day 14(day 14)
- mRS score 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)
研究者
研究点 (48)
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