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

Qianfoshan Hospital

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT07260760

YXLL-KY-2025(206)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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