NCT05644223

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

November 21, 2022

Last Update Submit

August 28, 2023

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic strokeedaravone dextrolreal-world study

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with modified Rankin Scale (mRS) score 0-1

    Proportion of patients with modified Rankin Scale (mRS) score (on a scale from 0 to 6, with higher scores indicating greater disability) of 0 to 1 at 90±7 days

    90±7 days

Secondary Outcomes (4)

  • Proportion of patients with mRS 0-2

    90±7 days

  • Distribution of mRS score

    90±7 days

  • Neurological functional change

    at discharge, an average of 7 days

  • Quality of Life (EQ-5D-5L) at 90 days

    90±7 days

Other Outcomes (4)

  • Symptomatic intracranial hemorrhage (sICH)

    during hospitalization, an average of 7 days

  • Intracranial hemorrhage during hospitalization (ICH)

    during hospitalization

  • All-cause death

    90±7 days

  • +1 more other outcomes

Study Arms (2)

Exposet group

intravenous edaravone dexborneol 37.5mg twice daily

Drug: edaravone dexborneol

Non-exposed group

standard treatment at the discretion of local clinicians

Interventions

edaravone dexborneolDRUG

intravenous edaravone dexborneol 37.5mg twice daily

Exposet group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Junwei Hao

Beijing, 100053, China

RECRUITING

Related Publications (2)

  • Ma G, Raynald, Arham A, Jiang Z, Mo R, Zuo Y, Wu Y, Meng S, Lei S, Nguyen TN, Zhong L; EXPAND investigators. Edaravone Dexborneol in Large Ischemic Stroke: Real-World Experience from a Multicenter Study in China. J Am Heart Assoc. 2026 Jan 6;15(1):e044296. doi: 10.1161/JAHA.125.044296. Epub 2025 Dec 30.

    PMID: 41467380DERIVED

  • Ma G, Mo R, Yao X, Nguyen TN, Song Z, Xie W, Yuan G, Zuo Y, Wu Y, Lei S, Meng S, Wu Y, Jiang Z, Liu H, Ren Y, Wang P, Gao D, Chang H, Guo Y, Zhang Q, Ma Q, Zhong L, Song H, Hao J. Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke: A Multicenter, Prospective, Cohort Study. Neurology. 2025 Aug 26;105(4):e213949. doi: 10.1212/WNL.0000000000213949. Epub 2025 Aug 5.

    PMID: 40763317DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neurology Department

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 9, 2022

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)