Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China

Официальное название

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

Обзор

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.

Первичные конечные точки

• Proportion of modified Rankin scale score 0-1 [Срок оценки: Day 90]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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
• NIHSS ≤ 5
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07322835 · RERISE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗