Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary endpoint indicators
研究概览
简要总结
EXCELLENT was a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study in which participants were randomized participants were randomized (1:1) to receive either IV thrombolysis + edaravone or IV thrombolysis + matched placebo (same volume of tablets without drug components), and the primary outcome was the proportion of patients with transformed bleeding on MRI at 72 hours following revascularization therapy.
详细描述
- Study on the effectiveness of neuroprotection combined with revascularization in the treatment of acute ischemic stroke in the ultra-early mobile stroke unit (MSU):
Based on the MSU model, using the RCT study design, for patients with disabling AIS within 4.5h, patients were randomly assigned 1:1 to the experimental group and the control group and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main evaluation index was the proportion of patients with transformed blood flow on MRI at 72 hours after receiving recanalization, and the other indexes included the patients' 90-day onset The remaining indicators include the modified Rankin Scale (mRS) score (hierarchical data), the proportion of patients with an mRS score of <1 at 90 days of onset, the proportion of patients with an mRS score of <2 at 90 days of onset, the time from onset to intravenous thrombolysis (in minutes), and the proportion of patients who received intravenous thrombolysis within 60 minutes of onset. 2. Safety study of ultra-early mobile stroke unit neuroprotection combined with revascularization for acute ischemic stroke:
Based on the MSU model, using the RCT study design for patients with disabling AIS within 4.5h, patients were 1:1 randomly assigned to the experimental group and control group, and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main safety evaluation indexes included all deaths during hospitalization, hospitalized deaths after receiving intravenous thrombolysis, deaths at 3 months after stroke, deaths at 3 months after receiving intravenous thrombolysis, and the proportion of symptomatic intracranial hemorrhage within 36 hours of the onset of the disease, and so on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years;
- •Acute ischemic stroke as defined by the International Health Organization (WHO) and confirmed by cranial CT;
- •Onset within a 4.5-hour time window;
- •NIHSS score of 6-24;
- •Meet the criteria for intravenous thrombolysis in acute ischemic stroke recommended by international guidelines;
- •Patient or family consent.
排除标准
- •Pregnant women, women in labor, and patients in the puerperium;
- •Comorbidity with other serious diseases that affect outcome determination;
- •Comorbidity with other serious diseases that affect prognostic regression;
- •Comorbidity with other serious diseases with a life expectancy of less than 1 year;
研究组 & 干预措施
Intravenous thrombolysis + edaravone (intervention group)
The patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. The method of intravenous t-PA thrombolysis is in accordance with the international guidelines: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a uniform rate within one hour.
干预措施: Intravenous thrombolysis + edaravone (Drug)
IV thrombolysis + placebo (control group)
Patients underwent intravenous t-PA thrombolysis + placebo sublingual administration. The method of intravenous t-PA thrombolysis is in accordance with the international guideline standards: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a constant rate within 1 hour.
干预措施: IV thrombolysis + placebo (control group) (Drug)
结局指标
主要结局
Primary endpoint indicators
时间窗: From the start of revascularization until 72 hours after treatment.
Proportion of patients with transformed bleeding on MRI at 72 hours after revascularization.
次要结局
- Secondary endpoint indicators(90 days after onset of illness)
研究者
Ruijun Ji
Chief Physician/Professor
Beijing Tiantan Hospital