NCT04817527Unknown2 期
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of symptomatic intracranial hemorrhage (sICH)
研究概览
简要总结
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
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
- Single (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
- •18 to 80 years of age;
- •Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI <31ml or with a NIHSS ≥20 and 31ml<Volume of infarction<51ml(DWI);
- •Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
- •Endovascular Therapy in 6-24 hours of stroke onset;
- •The availability of informed consent.
排除标准
- •First ever stroke or mRS≤1 after previous disease;
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •Severe cardiac or pulmonary disease;
- •Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
- •Pregnancy, plan to get pregnant or during lactation;
- •Patients with contraindication or allergic to any ingredient of drugs in our study;
- •Unsuitable for this clinical studies assessed by researcher
研究组 & 干预措施
Edaravone Dexborneol
Experimental
干预措施: Edaravone Dexborneol (Drug)
结局指标
主要结局
Proportion of symptomatic intracranial hemorrhage (sICH)
时间窗: 48 hours
Proportion of patients with modified Rankin Score 0 to 3 on day 90
时间窗: 90 days
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
时间窗: 90 days
次要结局
- Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14(14 days)
- Change in infarct volume(7 days)
- Midline shift on the CT scan(7 days)
- Proportion of death due to any cause(90 days)
- Proportion of Serious adverse events(SAE)(90 days)
- The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90(90 days)
- Serum inflammatory factors changes on day 1 and day 7(7 days)
- Proportion of PH1 and PH2 within 48 hours after the treatment(48 hours)
- Distribution of modified Rankin Score after the treatment(90 days)
- Activity of Daily Living Scale(ADL) score on day 14, 30, 90(90 days)
- Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90(90 days)
研究者
研究点 (1)
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