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NCT Number: NCT07322835

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location contact

Jinsheng Zeng, MD, PhD

CONTACT

[email protected]

+86-13322800657

Jinsheng Zeng, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of modified Rankin scale score 0-1

    Time frame: Day 90

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

Secondary outcomes

  1. Proportion of Modified Rankin Scale score 0-2

    Time frame: Day 90

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

  2. Proportion of Modified Rankin Scale score 0-3

    Time frame: Day 90

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

  3. Ordinal Modified Rankin Scale score

    Time frame: Day 90

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

  4. Change from baseline in National Institutes of Health Stroke Scale

    Time frame: Hour 24

    National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.

  5. Change from baseline in National Institutes of Health Stroke Scale

    Time frame: Hour 72

    National Institutes of Health Stroke Scale ranges from 0 to 42, and higher score indicates more severe neurologic deficits.

  6. National Institutes of Health Stroke Scale

    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.

  7. Barthel Index score

    Time frame: Day 90

    Barthel Index ranges from 0 to 100, and higher score means more functional independence.

  8. Proportion of patients with door-to-needle time < 60 minutes

    Time frame: immediately after the intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jinsheng Zeng, MD, PhD

CONTACT

[email protected]

+86-13322800657

Yicong Chen, MD, PhD

CONTACT

[email protected]

+86-15914325270

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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