An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of functional independence at 90 days
研究概览
简要总结
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.
详细描述
This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients presenting with anterior circulation acute ischemic stroke
- •Patients aged between 18-80 years.
- •CTA or DSA verified arterial occlusion of ICA, M1 or M
- •NIHSS on admission 4 - 26
- •Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8
- •Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time
排除标准
- •Patients without recanalization (TICI 0,1, 2a)
- •Pre-existing neurological disability (a score greater than 2 on the mRS)
- •Contraindication of edaravone dexborneol
研究组 & 干预措施
Edaravone dexborneol group
Patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group.
干预措施: Edaravone Dexborneol (Drug)
结局指标
主要结局
Proportion of functional independence at 90 days
时间窗: 90 days
Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
次要结局
- Growth in infarct volume (mL)(from 24 hours to 7 days)
- Salvaged ischemic tissue index (%)(from baseline to 7 days)
- Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day(from baseline to 1 day)
- Frequency of parenchymal hemorrhage (PH) (%)(24 hours)
- Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day(from 1 day to 7 days)
- Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1(90 days)
- Recovery assessed by modefied Rankin Scale (mRS) score(90 days)