Protective Effects of Edaravone Dexborneol

Last updated: September 3, 2021
Sponsor: Lili Cao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

N/A

Clinical Study ID

NCT05024526
FYQ2021
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged from 50 to 80 years old;
  2. Patients diagnosed as acute ischemic stroke according to Chinese guidelines for thediagnosis and treatment of acute ischemic stroke 2018 and who met the requirements ofmiddle 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 thatof DWI core infarct area, and the contralateral mirror brain tissue was basicallynormal;
  4. NIHSS score was between 4 to 24;
  5. Patient or their legal representatives were willing to sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Serious mental abnormality, complicated with heart, lung, liver, renal insufficiencyor 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 oraffect the clinical trial parameters.

Study Design

Total Participants: 80
Study Start date:
April 01, 2021
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

  • Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong 250014
    China

    Active - Recruiting

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