NCT04714177Unknown2 期
Efficacy and Safety of Edaravone Dexborneol in Addition to Standard of Care in Patients With Hypertensive Intracerebral Hemorrhage: a Randomized, Double-Blind, Placebo-Controlled Trial
First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 390 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 390
- 主要终点
- The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
研究概览
简要总结
pending
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from the patient or legally acceptable representative
- •Males and females
- •Diagnose as hypertensive intracerebral hemorrhage
- •Onset of symptoms within 6~48 hours
- •Position of bleeding major in basal ganglia
- •The sum of scores on items 5 and 6 on the NIHSS were >= 2 at baseline and the total score (items 1-11) was >=6 and <=20
- •Volume of Hematoma <= 30 ml
- •Premorbid mRS score of 0 or 1
排除标准
- •Allergy to known study drugs or excipients
- •Experienced stroke in latest 3 month
- •Volume of Hematoma > 5 ml in other bleeding position
- •Obstructive hydrocephalus
- •Any diagnosis as other than hypertensive ICH
- •Unconsciousness
- •Severe concurrent illness with life expectancy less than 90 days
- •Pregnancy or breast-feeding
研究组 & 干预措施
Edaravone Dexborneol
Experimental
Edaravone Dexborneol injection
干预措施: Edaravone Dexborneol (Drug)
Placebo
Placebo Comparator
Edaravone Dexborneol matching injection
干预措施: Placebo (Drug)
结局指标
主要结局
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
时间窗: 90 days after the first dose of study treatment
次要结局
- Barthel Index (BI)(90 days after the first dose of study treatment)
- The proportion of death(90 days after the first dose of study treatment)
- The proportionof Participants With modified Rankin Scale (mRS)(14, 30 and 90 days after the first dose of study treatment)
- The change in the NIH stroke scale (NIHSS) from the baseline(14, 30 and 90 days after the first dose of study treatment)
- The proportionof Participants With Glasgow Outcome Score (GOS)(14, 30 and 90 days after the first dose of study treatment)
- Stroke Specific Quality of Life Scale (SS-QOL)(90 days after the first dose of study treatment)
研究者
Jinsheng Zeng, MD, PhD
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University
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