Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke

NCT ID: NCT07260760

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-20

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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LI YAN

Chief Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofang Niu

Role: PRINCIPAL_INVESTIGATOR

Heze Municipal Hospital

Leqing Zhang

Role: PRINCIPAL_INVESTIGATOR

Yanggu County People's Hospital

Lei Duan

Role: PRINCIPAL_INVESTIGATOR

Zibo Central Hospital

Kai Ren

Role: PRINCIPAL_INVESTIGATOR

Haiyang People's Hospital

Rongrong Zhang

Role: PRINCIPAL_INVESTIGATOR

Sishui County People's Hospital

Ping Yang

Role: PRINCIPAL_INVESTIGATOR

Jinan Fourth People's Hospital

Ning Liu

Role: PRINCIPAL_INVESTIGATOR

Shandong Hospital of Integrated Traditional Chinese and Western Medicine

Pengcheng Du

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University, Dezhou Branch

Hui Liu

Role: PRINCIPAL_INVESTIGATOR

Jinan Municipal People's Hospital

Xi Rong

Role: PRINCIPAL_INVESTIGATOR

Weifang Yidu Central Hospital

Deyin Zhai

Role: PRINCIPAL_INVESTIGATOR

Linyi Traditional Chinese Medicine Hospital

Zhiqiang Zhang

Role: PRINCIPAL_INVESTIGATOR

Anqiu People's Hospital

Jiyong Wu

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Second People's Hospital

Meixia Wang

Role: PRINCIPAL_INVESTIGATOR

Jining Medical University Affiliated Hospital

Ping Wang

Role: PRINCIPAL_INVESTIGATOR

Liaocheng People's Hospital

Jiyao Li

Role: PRINCIPAL_INVESTIGATOR

Liaocheng Municipal People's Hospital

Central Contacts

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Yan Li

Role: CONTACT

13791126823

References

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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.

Reference Type RESULT
PMID: 38372981 (View on PubMed)

Other Identifiers

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YXLL-KY-2025(206)

Identifier Type: -

Identifier Source: org_study_id

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