Acute Ischemic StrokeIschemic strokNCT07260760
Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Qianfoshan Hospital.
Trial summary
This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 31 Dec 2028
- How long will I take part?
- 90 Days
- 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 ischemic stroke
Who may be able to join
- 1: Age≥18
- 2: Acute ischemic stroke in the anterior circulation occurring within 48 hours
- 3: Baseline NIHSS score of 1-15 points (mild stroke: baseline NIHSS score of 1-5 points; moderate stroke: baseline NIHSS score of 6-15 points)
- 4: Pre-onset mRS score≤1
- 5: Use of Edaravone (injection or tablets)
- 6: Exclude intracranial hemorrhage
- 7: Sign the informed consent form
Who cannot join
- 1: A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease
- 2: Patients with cerebral embolism or suspected cerebral embolism who also have severe atrioventricular block, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, or a heart rate below 50 beats per minute
- 3: Abnormal liver function (ALT or AST transaminase levels exceeding the upper limit of normal), abnormal kidney function (creatinine levels exceeding the upper limit of normal), or individuals with other severe systemic diseases, etc
- 4: Allergy to the test drug
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classification.
Read the detailed description
A comprehensive evaluation of commonly used clinical neuroprotective drugs was conducted, analyzing their practical application value in acute ischemic stroke treatment across six dimensions: safety, efficacy, cost-effectiveness, innovation, appropriateness, and accessibility. In a real-world clinical setting, this prospective observational study design primarily evaluates the association between edaravone and dexrazoxane usage and the efficacy and safety outcomes in patients with mild-to-moderate ischemic stroke, while conducting subgroup analyses based on different Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classifications.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Neuroprotective drugs, Real-world studies
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1
Measured: 90 days
Secondary outcomes (2)
Proportion of patients with mRS scores of 0-2
Measured: 30 days
Percentage reduction in National Institutes of Health Stroke Scale （NIHSS ）score compared to pre-treatment
Measured: 90 days after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- 600 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI YAN, Qianfoshan Hospital
- Investigators
- Xiaofang Niu, Principal investigator, Heze Municipal HospitalLeqing Zhang, Principal investigator, Yanggu County People's HospitalLei Duan, Principal investigator, Zibo Central HospitalKai Ren, Principal investigator, Haiyang People's HospitalRongrong Zhang, Principal investigator, Sishui County People's HospitalPing Yang, Principal investigator, Jinan Fourth People's HospitalNing Liu, Principal investigator, Shandong Hospital of Integrated Traditional Chinese and Western MedicinePengcheng Du, Principal investigator, Qilu Hospital of Shandong University, Dezhou Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260760
- Sponsor's protocol ID
- YXLL-KY-2025(206)
- Acronym
- Ischemic strok
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
PubMed 38372981
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07260760
- Acronym / sponsor ID
- Ischemic strok / YXLL-KY-2025(206)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Neuroprotective drugs, Real-world studies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Dec 2025 (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.
This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classification.
Detailed description
A comprehensive evaluation of commonly used clinical neuroprotective drugs was conducted, analyzing their practical application value in acute ischemic stroke treatment across six dimensions: safety, efficacy, cost-effectiveness, innovation, appropriateness, and accessibility. In a real-world clinical setting, this prospective observational study design primarily evaluates the association between edaravone and dexrazoxane usage and the efficacy and safety outcomes in patients with mild-to-moderate ischemic stroke, while conducting subgroup analyses based on different Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke
Key inclusion criteria (7 listed)
- 1: Age≥18
- 2: Acute ischemic stroke in the anterior circulation occurring within 48 hours
- 3: Baseline NIHSS score of 1-15 points (mild stroke: baseline NIHSS score of 1-5 points; moderate stroke: baseline NIHSS score of 6-15 points)
- 4: Pre-onset mRS score≤1
- 5: Use of Edaravone (injection or tablets)
Key exclusion criteria (4 listed)
- 1: A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease
- 2: Patients with cerebral embolism or suspected cerebral embolism who also have severe atrioventricular block, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, or a heart rate below 50 beats per minute
- 3: Abnormal liver function (ALT or AST transaminase levels exceeding the upper limit of normal), abnormal kidney function (creatinine levels exceeding the upper limit of normal), or individuals with other severe systemic diseases, etc
- 4: Allergy to the test drug
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 patients with Modified Rankin Scale（mRS ）scores of 0-1
Time frame: 90 days
2 secondary outcomes
Proportion of patients with mRS scores of 0-2
Time frame: 30 days
Percentage reduction in National Institutes of Health Stroke Scale （NIHSS ）score compared to pre-treatment
Time frame: 90 days after medication
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 15 Jan 2026.
- Results publication: PubMed 38372981Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
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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.
Xiaofang Niu principal investigator
Heze Municipal Hospital
Leqing Zhang principal investigator
Yanggu County People's Hospital
Lei Duan principal investigator
Zibo Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Qianfoshan Hospital.
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 4 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Li (13791126823, li_xyan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07260760, which also lists 1 linked publication.
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 15 Jan 2026.