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临床试验/NCT07322835
NCT07322835尚未招募不适用

Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China: A Multicenter Prospective Cohort Study

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 5,400 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,400
试验地点
1
主要终点
Proportion of modified Rankin scale score 0-1

研究概览

简要总结

Acute ischemic stroke is the most common type of stroke in China, accounting for 69.6% -72.8% of new strokes. In recent years, the proportion of mild stroke (NIHSS ≤ 5 points) has gradually increased, exceeding 50%, and the recurrence rate of stroke within one year is 13.2%, with a mortality rate of 6.3%, and 4% -10% may experience early deterioration of neurological function within 72 hours. At present, the main treatment for mild ischemic stroke is antiplatelet aggregation or anticoagulation drugs, but there are still 10% -20% of patients with residual neurological disability. There is still controversy over whether acute reperfusion therapy (including intravenous thrombolysis and endovascular intervention therapy) can improve the prognosis of such patients. In addition, it has been confirmed that beyond the time window thrombolysis is effective for selected ischemic stroke patients, but it is urgent to clarify whether mild ischemic stroke patients can benefit from receiving beyond the time window thrombolysis. Due to the limited evidence and inconsistent conclusions on the efficacy and safety of reperfusion therapy in patients with mild stroke, it is urgent to have a deeper understanding of the current status of reperfusion therapy for mild ischemic stroke in China based on real clinical data, and systematically compare the efficacy and safety of reperfusion therapy (including intravenous thrombolysis and endovascular intervention therapy) with standard drug therapy for this type of patient. This project plans to conduct a nationwide multicenter prospective cohort study to evaluate the differences in excellent neurological function prognosis (mRS ≤ 1) and symptomatic intracranial hemorrhage rate among patients with mild ischemic stroke who receive reperfusion therapy (intravenous thrombolysis ± endovascular intervention therapy) compared to standard drug therapy at 90 days, in order to guide accurate clinical decision-making. The research results have significant implications for improving the prognosis of patients with mild ischemic stroke, and will also lay an important foundation for future large-scale randomized controlled studies to explore the optimal treatment strategies for mild stroke.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 year
  • Pre-stroke mRS ≤1
  • Diagnosis of ischemic stroke, confirmed by imaging (CT or MRI)
  • Stroke onset or last seen well (LSW) to visit ≤ 24h
  • Receive standard medication or IVT (TNK or rtPA) ± EVT, or EVT alone; for IVT beyond standard time window, initiation of treatment must occur within 4.5-24h of last seen well and ASPECTs≥7 or Perfusion lesion-ischemic core mismatch (ischemic core volume <70mL, mismatch rate >1.2, mismatch volume >10mL or mismatch between the presence of an abnormal signal on DWI and no visible signal change on FLAIR)
  • Patients or their eligible surrogates provided informed consent

排除标准

  • Pregnant or breastfeeding women
  • Patients who already received reperfusion therapy for the current stroke before arriving at the hospital
  • Participation in another interventional clinical trial that could interfere with the outcomes of this study

研究组 & 干预措施

Reperfusion therapy cohort

intravenous thrombolysis ± endovascular therapy, endovascular therapy alone

Standard of care cohort

Recommended by guidelines for secondary stroke prevention, e.g. dual/mono antiplatelet, antihypertensive or lipid-lowing therapy, et al

结局指标

主要结局

Proportion of modified Rankin scale score 0-1

时间窗: Day 90

Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.

次要结局

  • Proportion of Modified Rankin Scale score 0-2(Day 90)
  • Proportion of Modified Rankin Scale score 0-3(Day 90)
  • Ordinal Modified Rankin Scale score(Day 90)
  • Change from baseline in National Institutes of Health Stroke Scale(Hour 72)
  • National Institutes of Health Stroke Scale(Day 7 or discharge (whichever comes first))
  • Barthel Index score(Day 90)
  • Proportion of patients with door-to-needle time < 60 minutes(immediately after the intervention)
  • Change from baseline in National Institutes of Health Stroke Scale(Hour 24)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinsheng Zeng, MD, PhD

Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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