NCT07260760

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

November 20, 2025

Last Update Submit

January 14, 2026

Conditions

Keywords

Acute ischemic strokeNeuroprotective drugsReal-world studies

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with Modified Rankin Scale(mRS )scores of 0-1

    90 days

Secondary Outcomes (2)

  • Proportion of patients with mRS scores of 0-2

    30 days

  • Percentage reduction in National Institutes of Health Stroke Scale (NIHSS )score compared to pre-treatment

    90 days after medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ischemic stroke

You may qualify if:

  • : Age≥18
  • : Acute ischemic stroke in the anterior circulation occurring within 48 hours
  • : 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)
  • : Pre-onset mRS score≤1
  • : Use of Edaravone (injection or tablets)
  • : Exclude intracranial hemorrhage
  • : Sign the informed consent form

You may not qualify if:

  • : A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease
  • : 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
  • : 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
  • : Allergy to the test drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Pharmacist

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 3, 2025

Study Start

January 20, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 15, 2026

Record last verified: 2026-01