Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- 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 3-month outcome in participants with acute ischemic stroke.
详细描述
Xingnaojing is widely used in China, but there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Xingnaojing will increase the proportion of people alive and independent at three months. Xingnaojing, combined with guidelines-based standard care, will be compared to standard care alone in patients with acute ischemic stroke within 24 hours of symptom onset. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 5-20. Patients in each group will be treated according to the guidelines-based standard care, including intravenous thrombolysis if appropriate. The primary outcome will be determined at 3 months.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke within 24 hours of symptom onset.
- •National Institutes of Health Stroke Scale score ≥ 5 and ≤
- •Age ≥ 35 and ≤ 80 years.
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Planned or already received endovascular treatment.
- •Suspected secondary stroke caused by tumor, brain trauma, or hematologic diseases.
- •Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ).
- •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, or aspartate aminotransferase value that is twice greater than the upper limit of normal).
- •Life expectancy of 90 days 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 and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
干预措施: Xingnaojing injection (Drug)
Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
干预措施: Standard care (Other)
Standard care only
Subjects will receive guidelines-based standard care only.
干预措施: Standard care (Other)
结局指标
主要结局
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.
次要结局
- Patient reported outcome (PRO) scale of stroke(10 days)
- Activities of daily living(30 days and 90 days)
- Deaths from any cause(10 days, 90 days)
- Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).(10 days)
- Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.(Baseline and 10 days.)
- Early neurologic deterioration (END)(Baseline and 48 hours)
- Symptomatic Intracranial Hemorrhage (sICH)(10 dyas)
- Cardiovascular events(90 days)
研究者
Ying Gao
Vice president of Dongzhimen Hospital
Dongzhimen Hospital, Beijing