NCT04817527

Brief Summary

To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 1, 2022

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

March 25, 2021

Last Update Submit

March 30, 2022

Conditions

Stroke, Ischemic

Keywords

Endovascular therapyExtended Time Windows

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients with modified Rankin Score 0 to 3 on day 90

    90 days

  • Proportion of symptomatic intracranial hemorrhage (sICH)

    48 hours

  • mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis

    90 days

Secondary Outcomes (11)

  • Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14

    14 days

  • Distribution of modified Rankin Score after the treatment

    90 days

  • Change in infarct volume

    7 days

  • The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90

    90 days

  • Activity of Daily Living Scale(ADL) score on day 14, 30, 90

    90 days

  • +6 more secondary outcomes

Study Arms (2)

Edaravone Dexborneol

EXPERIMENTAL
Drug: Edaravone Dexborneol

conventional therapy

NO INTERVENTION

conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy

Interventions

Edaravone DexborneolDRUG

Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.

Edaravone Dexborneol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years of age;
  • Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI \<31ml or with a NIHSS ≥20 and 31ml\<Volume of infarction\<51ml(DWI);
  • Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
  • Endovascular Therapy in 6-24 hours of stroke onset;
  • The availability of informed consent.

You may not qualify if:

  • First ever stroke or mRS≤1 after previous disease;
  • Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
  • Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
  • Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
  • Severe cardiac or pulmonary disease;
  • Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
  • Pregnancy, plan to get pregnant or during lactation;
  • Patients with contraindication or allergic to any ingredient of drugs in our study;
  • Unsuitable for this clinical studies assessed by researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jianfeng Han, MD

CONTACT

+8618991232708rabbit1110@163.com

Ying Tan, MD

CONTACT

+861358169376813581693768@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

April 1, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)