Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke (EXPAND)

Capital Medical University

Status

Enrolling

Conditions

Acute Ischemic Stroke

Treatments

Drug: edaravone dexborneol

Study type

Observational

Funder types

Other

Identifiers

NCT05644223

SMA-AIS-008

Details and patient eligibility

About

This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.

Full description

The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.

Enrollment

4,750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age≥18 years old；
Clinically diagnosed as acute ischemic stroke；
Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)；
Pre-stroke mRS ≤1；
Have been informed of the content of the informed consent form and agree to participate.

Exclusion criteria

Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.
Patients who are pregnant or lactating and who are planned to become pregnant within 90 days;
Patients with severe renal failure (eGFR<30ml/min);
Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days;
Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia;
Patients who are judged unsuitable for participation in the study.