StrokeNCT05121883
Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
An observational study of Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Edaravone Dexborneol
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Jan 2024
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 18-80 years with anterior circulation stroke obtaining successful recanalization after mechanical thrombectomy within 24 hours of onset will be included. CTP prior to mechanical thrombectomy must be performed to verify infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8. Patients without recanalization after mechanical thrombectomy or have a pre-mRS greater than 2 will be excluded.
Who may be able to join
- Patients presenting with anterior circulation acute ischemic stroke
- Patients aged between 18-80 years.
- CTA or DSA verified arterial occlusion of ICA, M1 or M2.
- NIHSS on admission 4 - 26
- Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8
- Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time
Who cannot join
- Patients without recanalization (TICI 0,1, 2a)
- Pre-existing neurological disability (a score greater than 2 on the mRS)
- Contraindication of edaravone dexborneol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Min Lou, PhD, MD, 13958007213, loumingxc@vip.sina.com
About this study
Official title: An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.
Read the detailed description
This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.
- Conditions
- Stroke
- Being tested
- Edaravone Dexborneol
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone DexborneolDrug
Edaravone dexborneol (Jiangsu Simcere Pharmaceutical, Co, Ltd) will be initiated within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days (maximum: 14 days)
| Study group | Role | What they receive |
|---|---|---|
| Edaravone dexborneol group | Patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group. Receives: Drug: Edaravone Dexborneol | |
| Standard medication group | Patients who do not recieve edaravone dexborneol will be classified into this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of functional independence at 90 days
Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
Measured: 90 days
Secondary outcomes (7)
Growth in infarct volume (mL)
24 hour infarct volume (mL) - 7 day infarct volume (mL)
Measured: from 24 hours to 7 days
Salvaged ischemic tissue index (%)
100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL)
Measured: from baseline to 7 days
Frequency of parenchymal hemorrhage (PH) (%)
The presence of PH is defined according the standard from ECASS-2 study thrombectomy
Measured: 24 hours
Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day
NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms
Measured: from baseline to 1 day
Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day
NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms
Measured: from 1 day to 7 days
Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1
mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
Measured: 90 days
Recovery assessed by modefied Rankin Scale (mRS) score
mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Lou, PhD, MD, Study chair, the 2nd affiliated hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121883
- Sponsor's protocol ID
- EDMETS
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Trial of Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05121883
- Acronym / sponsor ID
- EDMETS
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 16 Nov 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.
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.
Detailed description
This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edaravone dexborneol group | – | Drug: Edaravone DexborneolPatients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group. |
| Standard medication group | – | –Patients who do not recieve edaravone dexborneol will be classified into this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18-80 years with anterior circulation stroke obtaining successful recanalization after mechanical thrombectomy within 24 hours of onset will be included. CTP prior to mechanical thrombectomy must be performed to verify infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8. Patients without recanalization after mechanical thrombectomy or have a pre-mRS greater than 2 will be excluded.
Key inclusion criteria (6 listed)
- Patients presenting with anterior circulation acute ischemic stroke
- Patients aged between 18-80 years.
- CTA or DSA verified arterial occlusion of ICA, M1 or M2.
- NIHSS on admission 4 - 26
- Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8
Key exclusion criteria (3 listed)
- Patients without recanalization (TICI 0,1, 2a)
- Pre-existing neurological disability (a score greater than 2 on the mRS)
- Contraindication of edaravone dexborneol
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 DexborneolEdaravone dexborneol (Jiangsu Simcere Pharmaceutical, Co, Ltd) will be initiated within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days (maximum: 14 days) | Drug | Edaravone dexborneol group |
Primary outcome
Proportion of functional independence at 90 days
Time frame: 90 days
Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
7 secondary outcomes
Growth in infarct volume (mL)
Time frame: from 24 hours to 7 days
Salvaged ischemic tissue index (%)
Time frame: from baseline to 7 days
Frequency of parenchymal hemorrhage (PH) (%)
Time frame: 24 hours
Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day
Time frame: from baseline to 1 day
Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day
Time frame: from 1 day to 7 days
Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1
Time frame: 90 days
Recovery assessed by modefied Rankin Scale (mRS) score
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Min Lou, PhD, MD study chair
the 2nd affiliated hospital of Zhejiang University
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 Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 3 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 23 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?
Contact Min Lou, PhD, MD (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of functional independence at 90 days (time frame: 90 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 23 Aug 2023.