Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The proportion of patients independent.
研究概览
简要总结
The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.
详细描述
The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.
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
- •Diagnosis of Acute ischemic stroke；
- •Symptom onset within 24 hours；
- •Age ≥ 18 and ≤ 80 years；
- •NIHSS score ≥ 4 and ≤ 25；
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Planned or already receiving intravenous thrombolysis or endovascular treatment;
- •Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- •Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
- •Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
- •Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- •Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
- •Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
- •Other conditions that render outcomes or follow-up unlikely to be assessed;
- •Known to be pregnant or breastfeeding;
- •Currently receiving an investigational drug;
研究组 & 干预措施
Xingnaojing
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
干预措施: Xingnaojing injection (Drug)
Xingnaojing
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
干预措施: Standard care (Other)
Placebo
Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.
干预措施: Xingnaojing placebo injection (Drug)
Placebo
Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.
干预措施: Standard care (Other)
结局指标
主要结局
The proportion of patients independent.
时间窗: 90 days
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).
次要结局
- The proportion of patients independent at 30 days.(30 days)
- The recurrence rate of cerebrovascular events(Within 90 days)
- Safety end points(10 days)
- Early neurological deterioration.(Baseline and 3 days)
- Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).(Baseline and 10 days)
- Patient reported outcome(10 days)
- State of consciousness(48 hours and 7 days)
- Activities of daily living(30 days and 90 days)
- Stroke related deaths and deaths from any cause(Within 10 days and 90 days)
研究者
Ying Gao
President of the Institute for Encephalopathy, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing