Clinical trial NCT05024526: Protective Effects of Edaravone Dexborneol
Official title: Protective Effects of Edaravone Dexborneol in Patients With Acute Ischemic Stroke by Improving Ischemic Penumbra and Collateral Circulation of Hypoperfusion Areas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: edaravone dexborneol
ischemic penumbra
NIHSS
mRS
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: image changes in different groups
timeFrame: 7 days
Secondary outcomes:
measure: NIHSS changes in different groups
timeFrame: 7days，14 days, 90 days
measure: mRS changes in different groups
timeFrame: 7days，14 days, 90 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
name: Yu-Qing Fang, MD
role: PRINCIPAL_INVESTIGATOR
References: