Protective Effects of Edaravone Dexborneol

Sponsor

Lili Cao (Other)

Overall Status

Recruiting

CT.gov ID

NCT05024526

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: edaravone dexborneol or edaravone	N/A

Detailed Description

A total of 80 patients with acute ischemic stroke of middle cerebral artery were randomly divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The mismatch area between the low perfusion area of MRI 3D-ASL and the infarct area of DWI was defined as the ischemic penumbra, and the CBF perfusion pseudo color images with PLD of 1.5s and 2.5s were recorded. The above two CBF perfusion images were subtracted, and the residual area was quantitatively analyzed to reflect the establishment of collateral circulation. We aimed to observe whether there were differences in the improvement of ischemic penumbra and the establishment of collateral circulation between two groups after treatment. Besides, the improvment of NIHSS and mRS was also observed in different periods.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Protective Effects of Edaravone Dexborneol in Patients With Acute Ischemic Stroke by Improving Ischemic Penumbra and Collateral Circulation of Hypoperfusion Areas

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: edaravone dexborneol group	Drug: edaravone dexborneol or edaravone Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.
Active Comparator: edaravone group	Drug: edaravone dexborneol or edaravone Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.

Arm

Intervention/Treatment

Experimental: edaravone dexborneol group

Drug: edaravone dexborneol or edaravone

Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.

Active Comparator: edaravone group

Drug: edaravone dexborneol or edaravone

Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.

Outcome Measures

Primary Outcome Measures

image changes in different groups [7 days]

Secondary Outcome Measures

NIHSS changes in different groups [7days，14 days, 90 days]
mRS changes in different groups [7days，14 days, 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.