Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07260760

Acronym

Ischemic strok

Enrollment

600

Registered

2025-12-03

Start date

2026-01-20

Completion date

2028-12-31

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke, Neuroprotective drugs, Real-world studies

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Contacts

Primary ContactYan Li

li_xyan@126.com13791126823

Outcome results