The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Location contact
Jinsheng Zeng, MD, PhD
CONTACT
Jinsheng Zeng, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07322835
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Guangzhou, Guangdong, 510080, China
Jinsheng Zeng, MD, PhD
CONTACT
Jinsheng Zeng, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 90
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Time frame: Day 90
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Time frame: Day 90
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Time frame: Day 90
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Time frame: Hour 24
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.
Time frame: Hour 72
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.
Time frame: Day 7 or discharge (whichever comes first)
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.
Time frame: Day 90
Barthel Index ranges from 0 to 100, and higher score means more functional independence.
Time frame: immediately after the intervention
Time frame: Day 7 or discharge
Time frame: Day 7 or discharge
Time frame: Day 90
Contact information is provided by the study sponsor or research team.
Jinsheng Zeng, MD, PhD
CONTACT
Yicong Chen, MD, PhD
CONTACT
First Affiliated Hospital, Sun Yat-Sen University
Other
Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China: A Multicenter Prospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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