Protective Effects of Edaravone Dexborneol

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024526
• Other study ID #: FYQ2021
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2021
• Source: Qianfoshan Hospital
• Contact: Yu-Qing Fang, MD
• Phone: +8618866883808
• Email: perfectin2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital,The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Lili Cao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	image changes in different groups		7 days
Secondary	NIHSS changes in different groups		7days,14 days, 90 days
Secondary	mRS changes in different groups		7days,14 days, 90 days