Protective Effects of Edaravone Dexborneol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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edaravone dexborneol group

Group Type EXPERIMENTAL

edaravone dexborneol or edaravone

Intervention Type DRUG

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

edaravone group

Group Type ACTIVE_COMPARATOR

edaravone dexborneol or edaravone

Intervention Type DRUG

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

Interventions

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edaravone dexborneol or edaravone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged from 50 to 80 years old;
2. 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;
3. 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;
4. NIHSS score was between 4 to 24;
5. Patient or their legal representatives were willing to sign the informed consent form.

Exclusion Criteria

1. Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
2. Combined with cerebral vascular malformation or cerebral hemorrhage;
3. Pregnant or lactating women;
4. Allergic to edaravone or dexborneol;
5. There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No