Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke (Ischemic strok)

January 14, 2026 updated by: LI YAN, Qianfoshan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with ischemic stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with mRS scores of 0-2
Time Frame: 30 days
30 days
Percentage reduction in National Institutes of Health Stroke Scale （NIHSS ）score compared to pre-treatment
Time Frame: 90 days after medication
90 days after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Xiaofang Niu, Heze Municipal Hospital
  • Principal Investigator: Leqing Zhang, Yanggu County People's Hospital
  • Principal Investigator: Lei Duan, Zibo Central Hospital
  • Principal Investigator: Kai Ren, Haiyang People's Hospital
  • Principal Investigator: Rongrong Zhang, Sishui County People's Hospital
  • Principal Investigator: Ping Yang, Jinan Fourth People's Hospital
  • Principal Investigator: Ning Liu, Shandong Hospital of Integrated Traditional Chinese and Western Medicine
  • Principal Investigator: Pengcheng Du, Qilu Hospital of Shandong University, Dezhou Branch
  • Principal Investigator: Hui Liu, Jinan Municipal People's Hospital
  • Principal Investigator: Xi Rong, Weifang Yidu Central Hospital
  • Principal Investigator: Deyin Zhai, Linyi Traditional Chinese Medicine Hospital
  • Principal Investigator: Zhiqiang Zhang, Anqiu People's Hospital
  • Principal Investigator: Jiyong Wu, Shandong Provincial Second People's Hospital
  • Principal Investigator: Meixia Wang, Jining Medical University Affiliated Hospital
  • Principal Investigator: Ping Wang, Liaocheng people's Hospital
  • Principal Investigator: Jiyao Li, Liaocheng Municipal People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2025(206)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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