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NCT Number: NCT07260760

Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

  1. Proportion of patients with mRS scores of 0-2

    Time frame: 30 days

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

    Time frame: 90 days after medication

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Acronym: Ischemic strok

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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