NCT01929096已完成2 期
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 28
- 主要终点
- Change from baseline NIHSS score on day 14
研究概览
简要总结
- To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;
- To provide evidence for the design of Compound Edaravone Injection Phase III trial.
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 75 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 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.
研究组 & 干预措施
High-dose group
Experimental
Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
干预措施: Compound Edaravone Injection (Drug)
Control group
Active Comparator
Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days
干预措施: Edaravone Injection (Drug)
Low-dose group
Experimental
Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
干预措施: Compound Edaravone Injection (Drug)
Medium-dose group
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)
结局指标
主要结局
Change from baseline NIHSS score on day 14
时间窗: day 14
mRS score on day 90
时间窗: day 90
次要结局
- 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)
- 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 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 (28)
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