Protective Effects of Edaravone Dexborneol

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: edaravone dexborneol or edaravone

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Qing Fang, MD; Phone Number: +8618866883808; Email: perfectin2000@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
      • Contact: Lili Cao, PH.D; Email: qykyc309@163.com
      • Principal Investigator: Yu-Qing Fang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
image changes in different groups	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
NIHSS changes in different groups	7days，14 days, 90 days
mRS changes in different groups	7days，14 days, 90 days

Collaborators and Investigators

• Sponsor: Lili Cao
• Investigators: Principal Investigator: Yu-Qing Fang, MD, Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ischemic penumbra; NIHSS; mRS; edaravone dexborneol
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: FYQ2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No