NCT04667637已完成2 期
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study
Hui-Sheng Chen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients with modified Rankin Score 0 to 2
研究概览
简要总结
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.
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
- Double (Participant, Investigator)
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;
- •Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
- •Sufficient recanalization within 9 hours of stroke onset;
- •Sufficient recanalization （TICI 2b-3）;
- •Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;
- •First ever stroke or mRS≤1 after previous disease
- •The availability of informed consent.
排除标准
- •Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）
- •Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;
- •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 hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- •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
0.9% NaCl
Placebo Comparator
Intravenous injections of 0.9% NaCl BID for 12 ±2days.
干预措施: edaravone dexborneol (Drug)
Edaravone Dexborneol
Experimental
Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.
干预措施: edaravone dexborneol (Drug)
结局指标
主要结局
Proportion of patients with modified Rankin Score 0 to 2
时间窗: Day 90
Proportion of patients with modified Rankin Score 0 to 2
次要结局
- Distribution of modified Rankin Score(Day 90)
- Change in infarct volume(1 week)
- Proportion of patients with modified Rankin Score 0 to 1(Day 90)
- Changes in National Institute of Health stroke scale (NIHSS)(24 hours, 48 hours, and 2 weeks)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
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