Protective Effects of Edaravone Dexborneol
1 other identifier
interventional
80
1 country
1
Brief Summary
The patients of acute ischemic stroke were divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The purpose of this study was to observe the changes of imaging and the improvement of NIHSS and mRS in different groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedSeptember 13, 2021
September 1, 2021
1.8 years
August 23, 2021
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
image changes in different groups
7 days
Secondary Outcomes (2)
NIHSS changes in different groups
7days，14 days, 90 days
mRS changes in different groups
7days，14 days, 90 days
Study Arms (2)
edaravone dexborneol group
EXPERIMENTALedaravone group
ACTIVE COMPARATORInterventions
Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.
Eligibility Criteria
You may qualify if:
- Aged from 50 to 80 years old;
- Patients diagnosed as acute ischemic stroke according to Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018 and who met the requirements of middle cerebral artery blood supply area infarction (except deep perforator disease) without treatment;
- Brain MR showed that the low perfusion area of ASL was at least 20% larger than that of DWI core infarct area, and the contralateral mirror brain tissue was basically normal;
- NIHSS score was between 4 to 24;
- Patient or their legal representatives were willing to sign the informed consent form.
You may not qualify if:
- Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
- Combined with cerebral vascular malformation or cerebral hemorrhage;
- Pregnant or lactating women;
- Allergic to edaravone or dexborneol;
- There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lili Caolead
Study Sites (1)
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Qing Fang, MD
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 27, 2021
Study Start
April 1, 2021
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share