Minor Ischemic StrokeNCT07322835
Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China
An observational study of Minor Ischemic Stroke, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minor Ischemic Stroke
- Type of treatment
- Injection or infusion
- How many people
- 5,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with minor ischemic stroke (NIHSS ≤ 5) within 24h from onset
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Jinsheng Zeng, MD, PhD, +86-13322800657, zengjsh@mail.sysu.edu.cn
Jinsheng Zeng, MD, PhD
About this study
Official title: 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.
- Conditions
- Minor Ischemic Stroke
- Keywords
- minor ischemic stroke, reperfusion therapy, intravenous thrombolysis, endovascular therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of modified Rankin scale score 0-1
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Measured: Day 90
Secondary outcomes (8)
Proportion of Modified Rankin Scale score 0-2
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Measured: 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.
Measured: Day 90
Ordinal Modified Rankin Scale score
Modified Rankin Scale score ranges from 0 to 6, and lower score means better functional independence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 or discharge (whichever comes first)
Barthel Index score
Barthel Index ranges from 0 to 100, and higher score means more functional independence.
Measured: Day 90
Proportion of patients with door-to-needle time < 60 minutes
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jinsheng Zeng, MD, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322835
- Sponsor's protocol ID
- RERISE
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07322835
- Acronym / sponsor ID
- RERISE
- Conditions
- Minor Ischemic Stroke
- Keywords
- minor ischemic stroke, reperfusion therapy, intravenous thrombolysis, endovascular therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with minor ischemic stroke (NIHSS ≤ 5) within 24h from onset
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinsheng Zeng, MD, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minor Ischemic Stroke, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinsheng Zeng, MD, PhD (+86-13322800657, zengjs@pub.guangzhou.gd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of modified Rankin scale score 0-1 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.