A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Xueshuantong Lyophilized Powder in Chinese Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
研究概览
简要总结
The aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.
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.
- •Patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle.
- •4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time.
- •Female or male aged ≥ 18 years and ≤ 80 years.
- •Provision of signed informed consent prior to any study-specific procedure.
排除标准
- •Patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization.
- •Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or other diseases with the explicit diagnosis.
- •mRS grade ≥ 2 pre-morbid historical assessment.
- •Other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).
- •Known severe impairment of liver function or renal function.
- •Known hypersensitivity to study drugs.
- •Known severe comorbidity with life expectancy < 3 months.
- •Known massive cerebral infarction combined with disturbance of consciousness (1a ≥ 2 in NIHSS), dementia, mental impairment, or unsuitable for participation, in the opinion of the investigator.
- •Pregnancy or breastfeeding.
- •Participation in another clinical study with an investigational product at any time during the 3 months prior to randomization (regardless of when treatment with the investigational product was discontinued).
研究组 & 干预措施
Xueshuantong
Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.
干预措施: Xueshuantong lyophilized powder (Drug)
Xueshuantong
Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.
干预措施: Guidelines-based standard care (Other)
Placebo
Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.
干预措施: Placebo (Drug)
Placebo
Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.
干预措施: Guidelines-based standard care (Other)
结局指标
主要结局
Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
时间窗: Day 10 ± 2
The aim is to assess the effects of Xueshuantong lyophilized powder versus placebo on reducing the neurological impairment when initiated within 72 hours of symptom onset in patients with acute ischemic stroke. The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
次要结局
- Incidence of treatment-related adverse events(Up to Day 90)
- The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)(Day 10 ± 2)
- The proportion of patients with modified Rankin Scale grade ≤1 on day 90(Day 90 ± 7)
- The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90(Day 90 ± 7)
- Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)(Day 10 ± 2)
- Quality of life of patients measured by Stroke-specific quality of life scale on day 90(Day 90 ± 7)
研究者
Ying Gao
President of Institute for Brain Disorders, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing