Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Minor Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China: A Multicenter Prospective Cohort Study
Overview
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.
Primary outcome measures
- Proportion of modified Rankin scale score 0-1 [Time frame: Day 90]
Secondary outcome measures (8)
- Proportion of Modified Rankin Scale score 0-2 [Time frame: Day 90]
- Proportion of Modified Rankin Scale score 0-3 [Time frame: Day 90]
- Ordinal Modified Rankin Scale score [Time frame: Day 90]
- Change from baseline in National Institutes of Health Stroke Scale [Time frame: Hour 24]
- Change from baseline in National Institutes of Health Stroke Scale [Time frame: Hour 72]
- National Institutes of Health Stroke Scale [Time frame: Day 7 or discharge (whichever comes first)]
- Barthel Index score [Time frame: Day 90]
- Proportion of patients with door-to-needle time < 60 minutes [Time frame: immediately after the intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT07322835 · RERISE