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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,400 Participants
are grouped into 2 trial groups
Group A: Reperfusion therapy cohort
Group B: Standard of care cohort

Trial outcomes

Primary outcomes

1

Proportion of modified Rankin scale score 0-1

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

Time frame
Day 90

Secondary outcomes

1

Proportion of Modified Rankin Scale score 0-2

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

Time frame
Day 90
2

Proportion of Modified Rankin Scale score 0-3

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

Time frame
Day 90
3

Ordinal Modified Rankin Scale score

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

Time frame
Day 90
4

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.

Time frame
Hour 24

Other outcomes

1

Proportion of symptomatic intracerebral hemorrhage (ECASS III)

Time frame
Day 7 or discharge
2

Proportion of moderate or severe systemic bleeding (The GUSTO criteria)

Time frame
Day 7 or discharge
3

Mortality

Time frame
Day 90

Sponsors and contacts

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