CClinicalTrials.gg
Status unknownNCT05024526Updated Sep 13, 2021

Protective Effects of Edaravone Dexborneol

An interventional study of edaravone dexborneol or edaravone in Acute Ischemic Stroke, sponsored by Lili Cao. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Lili Cao · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2021, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • edaravone dexborneol
  • ischemic penumbra
  • NIHSS
  • mRS
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Lili Cao is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    edaravone dexborneol group

    Drug: edaravone dexborneol or edaravone

  • Active comparator
    edaravone group

    Drug: edaravone dexborneol or edaravone

Interventions

  • Drugedaravone dexborneol or edaravone

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

06

What researchers measure

Primary outcomes

  1. image changes in different groups

    Time frame: 7 days

Secondary outcomes

  1. NIHSS changes in different groups

    Time frame: 7days,14 days, 90 days

  2. mRS changes in different groups

    Time frame: 7days,14 days, 90 days

07

Study locations

1 of 1 sites recruiting
  • Shandong Provincial Qianfoshan Hospital,The First Affiliated Hospital of Shandong First Medical University
    Jinan, Shandong 250014, China
    • Lili Cao, Ph.D · Contact · qykyc309@163.com
    • Yu-Qing Fang, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05024526
Lead sponsor
Lili Cao
Responsible party
Lili Cao (Professor, Qianfoshan Hospital) — Sponsor-investigator
First posted
Aug 27, 2021
Start date
Apr 1, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Sep 13, 2021

Study contacts

Yu-Qing Fang, MD
Contact
perfectin2000@163.com
+8618866883808
Yu-Qing Fang, MD
principal investigator · Shandong Provincial Qianfoshan Hospital,The First Affiliated Hospital of Shandong First Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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