Acute Ischemic StrokeEXPANDNCT05644223
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- edaravone dexborneol
- Type of treatment
- Injection or infusion
- How many people
- 4,750 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this study.
Who may be able to join
- Age≥18 years old；
- Clinically diagnosed as acute ischemic stroke；
- Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)；
- Pre-stroke mRS ≤1；
- Have been informed of the content of the informed consent form and agree to participate.
Who cannot join
- Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.
- Patients who are pregnant or lactating and who are planned to become pregnant within 90 days;
- Patients with severe renal failure (eGFR<30ml/min);
- Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days;
- Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia;
- Patients who are judged unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junwei Hao
Beijing, 100053
Junwei Hao, MD, 01083198277, haojunwei@vip.163.com
About this study
Official title: Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.
Read the detailed description
The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.
- Conditions
- Acute Ischemic Stroke
- Being tested
- edaravone dexborneol
- Keywords
- acute ischemic stroke, edaravone dextrol, real-world study
- 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 dexborneolDrug
intravenous edaravone dexborneol 37.5mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Exposet group | intravenous edaravone dexborneol 37.5mg twice daily Receives: Drug: edaravone dexborneol | |
| Non-exposed group | standard treatment at the discretion of local clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with modified Rankin Scale (mRS) score 0-1
Proportion of patients with modified Rankin Scale (mRS) score (on a scale from 0 to 6, with higher scores indicating greater disability) of 0 to 1 at 90±7 days
Measured: 90±7 days
Secondary outcomes (4)
Proportion of patients with mRS 0-2
Proportion of patients with mRS score of 0 to 2 at 90±7 days
Measured: 90±7 days
Distribution of mRS score
Distribution of mRS score at 90±7 days
Measured: 90±7 days
Neurological functional change
The change of NIHSS score at discharge compared with the baseline NIHSS score
Measured: at discharge, an average of 7 days
Quality of Life (EQ-5D-5L) at 90 days
The value of EQ-5D-5L at 90±7 days
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,750 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwei Hao, MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644223
- Sponsor's protocol ID
- SMA-AIS-008
- Acronym
- EXPAND
- Status last verified
- Aug 2023
- First submitted
- 21 Nov 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma G, Raynald, Arham A, Jiang Z, Mo R, Zuo Y, Wu Y, Meng S, Lei S, Nguyen TN, Zhong L; EXPAND investigators. Edaravone Dexborneol in Large Ischemic Stroke: Real-World Experience from a Multicenter Study in China. J Am Heart Assoc. 2026 Jan 6;15(1):e044296. doi: 10.1161/JAHA.125.044296. Epub 2025 Dec 30.
PubMed 41467380Ma G, Mo R, Yao X, Nguyen TN, Song Z, Xie W, Yuan G, Zuo Y, Wu Y, Lei S, Meng S, Wu Y, Jiang Z, Liu H, Ren Y, Wang P, Gao D, Chang H, Guo Y, Zhang Q, Ma Q, Zhong L, Song H, Hao J. Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke: A Multicenter, Prospective, Cohort Study. Neurology. 2025 Aug 26;105(4):e213949. doi: 10.1212/WNL.0000000000213949. Epub 2025 Aug 5.
PubMed 40763317
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke: a Multicenter, Prospective, Patient-centered, Real-world Cohort Study
- ClinicalTrials.gov ID
- NCT05644223
- Acronym / sponsor ID
- EXPAND / SMA-AIS-008
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, edaravone dextrol, real-world study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,750 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 Dec 2022 (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.
This study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.
Detailed description
The study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. Treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. The exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. The non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. Follow-up period: All patients continue to be followed up to 90 days after stroke onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposet group | – | Drug: edaravone dexborneolintravenous edaravone dexborneol 37.5mg twice daily |
| Non-exposed group | – | –standard treatment at the discretion of local clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who aged more than 18 years old and diagnosed as acute ischemic stroke (time from symptom onset to admission ≤ 14 days) with pre-stroke mRS ≤1 can be enrolled in this study.
Key inclusion criteria (5 listed)
- Age≥18 years old；
- Clinically diagnosed as acute ischemic stroke；
- Time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)；
- Pre-stroke mRS ≤1；
- Have been informed of the content of the informed consent form and agree to participate.
Key exclusion criteria (6 listed)
- Acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.
- Patients who are pregnant or lactating and who are planned to become pregnant within 90 days;
- Patients with severe renal failure (eGFR<30ml/min);
- Patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days;
- Patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia;
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 dexborneolintravenous edaravone dexborneol 37.5mg twice daily | Drug | Exposet group |
Primary outcome
Proportion of patients with modified Rankin Scale (mRS) score 0-1
Time frame: 90±7 days
Proportion of patients with modified Rankin Scale (mRS) score (on a scale from 0 to 6, with higher scores indicating greater disability) of 0 to 1 at 90±7 days
4 secondary outcomes
Proportion of patients with mRS 0-2
Time frame: 90±7 days
Distribution of mRS score
Time frame: 90±7 days
Neurological functional change
Time frame: at discharge, an average of 7 days
Quality of Life (EQ-5D-5L) at 90 days
Time frame: 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 41467380Ma G, Raynald, Arham A, Jiang Z, Mo R, Zuo Y, Wu Y, Meng S, Lei S, Nguyen TN, Zhong L; EXPAND investigators. Edaravone Dexborneol in Large Ischemic Stroke: Real-World Experience from a Multicenter Study in China. J Am Heart Assoc. 2026 Jan 6;15(1):e044296. doi: 10.1161/JAHA.125.044296. Epub 2025 Dec 30.
- Derived from this study: PubMed 40763317Ma G, Mo R, Yao X, Nguyen TN, Song Z, Xie W, Yuan G, Zuo Y, Wu Y, Lei S, Meng S, Wu Y, Jiang Z, Liu H, Ren Y, Wang P, Gao D, Chang H, Guo Y, Zhang Q, Ma Q, Zhong L, Song H, Hao J. Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke: A Multicenter, Prospective, Cohort Study. Neurology. 2025 Aug 26;105(4):e213949. doi: 10.1212/WNL.0000000000213949. Epub 2025 Aug 5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing 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 6 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 31 Aug 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Scale (mRS) score 0-1 (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644223, which also lists 2 linked publications.
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 31 Aug 2023.