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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Minor Ischemic Stroke

• Study Type: Observational
• Enrollment (Estimated): 5400

Contacts and Locations

• Study Contact: Name: Jinsheng Zeng, MD, PhD; Phone Number: +86-13322800657; Email: zengjs@pub.guangzhou.gd.cn
• Study Contact Backup: Name: Yicong Chen, MD, PhD; Phone Number: +86-15914325270; Email: chenyc37@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Jinsheng Zeng, MD, PhD; Phone Number: +86-13322800657; Email: zengjsh@mail.sysu.edu.cn
      • Principal Investigator: Jinsheng Zeng, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with minor ischemic stroke (NIHSS ≤ 5) within 24h from onset

Description

Inclusion Criteria:

1. Age >18 year
2. Pre-stroke mRS ≤1
3. Diagnosis of ischemic stroke, confirmed by imaging (CT or MRI)
4. Stroke onset or last seen well (LSW) to visit ≤ 24h
5. NIHSS ≤ 5
6. 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)
7. Patients or their eligible surrogates provided informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Patients who already received reperfusion therapy for the current stroke before arriving at the hospital
3. Participation in another interventional clinical trial that could interfere with the outcomes of this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Reperfusion therapy cohort; intravenous thrombolysis ± endovascular therapy, endovascular therapy alone
Standard of care cohort; Recommended by guidelines for secondary stroke prevention, e.g. dual/mono antiplatelet, antihypertensive or lipid-lowing therapy, et al

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of modified Rankin scale score 0-1	Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Modified Rankin Scale score 0-2	Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.	Day 90
Proportion of Modified Rankin Scale score 0-3	Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.	Day 90
Ordinal Modified Rankin Scale score	Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.	Day 90
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.	Hour 24
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.	Hour 72
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.	Day 7 or discharge (whichever comes first)
Barthel Index score	Barthel Index ranges from 0 to 100, and higher score means more functional independence.	Day 90
Proportion of patients with door-to-needle time < 60 minutes		immediately after the intervention

Other Outcome Measures

Outcome Measure	Time Frame
Mortality	Day 90
Proportion of symptomatic intracerebral hemorrhage (ECASS III)	Day 7 or discharge
Proportion of moderate or severe systemic bleeding (The GUSTO criteria)	Day 7 or discharge

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: intravenous thrombolysis; reperfusion therapy; endovascular therapy; minor ischemic stroke
• Other Study ID Numbers: RERISE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No