Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke

Last updated: August 28, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Occlusions

Treatment

edaravone dexborneol

Clinical Study ID

NCT05644223
SMA-AIS-008
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 lastknown well time);
  • Pre-stroke mRS ≤1;
  • Have been informed of the content of the informed consent form and agree toparticipate.

Exclusion

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 estimatedsurvival of less than 90 days;
  • Patients with severe mental disorders or unable to complete the informed consent andfollow-up due to dementia;
  • Patients who are judged unsuitable for participation in the study.

Study Design

Total Participants: 4750
Treatment Group(s): 1
Primary Treatment: edaravone dexborneol
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Junwei Hao

    Beijing, 100053
    China

    Active - Recruiting

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