About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with minor ischemic stroke (NIHSS ≤ 5) within 24h from onset
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of modified Rankin scale score 0-1
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Secondary outcomes
Proportion of Modified Rankin Scale score 0-2
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Proportion of Modified Rankin Scale score 0-3
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Ordinal Modified Rankin Scale score
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Change from baseline in National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.
Other outcomes
Proportion of symptomatic intracerebral hemorrhage (ECASS III)
Proportion of moderate or severe systemic bleeding (The GUSTO criteria)
Mortality
Sponsors and contacts
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