Acute Ischemic StrokeNCT05024526
Protective Effects of Edaravone Dexborneol
A study testing edaravone dexborneol or edaravone in people with Acute Ischemic Stroke, run by Lili Cao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- edaravone dexborneol or edaravone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 50 to 80 years old;
- 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;
- 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;
- NIHSS score was between 4 to 24;
- Patient or their legal representatives were willing to sign the informed consent form.
Who cannot join
- Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
- Combined with cerebral vascular malformation or cerebral hemorrhage;
- Pregnant or lactating women;
- Allergic to edaravone or dexborneol;
- There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Lili Cao, Ph.D, qykyc309@163.com
Yu-Qing Fang, MD
About this study
Official title: 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.
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- edaravone dexborneol or edaravone
- Keywords
- edaravone dexborneol, ischemic penumbra, NIHSS, mRS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edaravone dexborneol or edaravoneDrug
Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.
| Study group | Role | What they receive |
|---|---|---|
| edaravone dexborneol group | Experimental | Not described Receives: Drug: edaravone dexborneol or edaravone |
| edaravone group | Active comparator | Not described Receives: Drug: edaravone dexborneol or edaravone |
What is being measured
The primary outcome is the main question the study is designed to answer.
image changes in different groups
Measured: 7 days
Secondary outcomes (2)
NIHSS changes in different groups
Measured: 7days，14 days, 90 days
mRS changes in different groups
Measured: 7days，14 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lili Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yu-Qing Fang, MD, Principal investigator, Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024526
- Sponsor's protocol ID
- FYQ2021
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Edaravone Dexborneol in Patients With Acute Ischemic Stroke by Improving Ischemic Penumbra and Collateral Circulation of Hypoperfusion Areas
- ClinicalTrials.gov ID
- NCT05024526
- Acronym / sponsor ID
- FYQ2021
- Conditions
- Acute Ischemic Stroke
- Keywords
- edaravone dexborneol, ischemic penumbra, NIHSS, mRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lili CaoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| edaravone dexborneol group | Experimental | Drug: edaravone dexborneol or edaravone |
| edaravone group | Active comparator | Drug: edaravone dexborneol or edaravone |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 50 to 80 years old;
- 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;
- 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;
- NIHSS score was between 4 to 24;
- Patient or their legal representatives were willing to sign the informed consent form.
Key exclusion criteria (5 listed)
- Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
- Combined with cerebral vascular malformation or cerebral hemorrhage;
- Pregnant or lactating women;
- Allergic to edaravone or dexborneol;
- There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edaravone dexborneol or edaravoneEdaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy. | Drug | edaravone dexborneol group, edaravone group |
Primary outcome
image changes in different groups
Time frame: 7 days
2 secondary outcomes
NIHSS changes in different groups
Time frame: 7days，14 days, 90 days
mRS changes in different groups
Time frame: 7days，14 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Qing Fang, MD principal investigator
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing edaravone dexborneol or edaravone in people with Acute Ischemic Stroke, run by Lili Cao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Qing Fang, MD (+8618866883808, perfectin2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
image changes in different groups (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.