StrokePhase 2NCT04667637

Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

A Phase 2 study testing edaravone dexborneol in people with Stroke and Endovascular Thrombectomy, run by Hui-Sheng Chen at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Endovascular Thrombectomy
What is being tested?: edaravone dexborneol
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteChina
Study dates: 23 Feb 2021to 10 Oct 2022
Phase: Phase 2
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

Who may be able to join

18 to 80 years of age;
Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
Sufficient recanalization within 9 hours of stroke onset;
Sufficient recanalization （TICI 2b-3）;
Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;
First ever stroke or mRS≤1 after previous disease
The availability of informed consent.

Who cannot join

Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）
Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);

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Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
Pregnancy, plan to get pregnant or during lactation;
Patients with contraindication or allergic to any ingredient of drugs in our study;
Unsuitable for this clinical studies assessed by researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

General Hospital of Northern Theater Command
Shenyang, 110840

Other trials in China

About this study

Official title: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.

Conditions: Stroke, Endovascular Thrombectomy
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
Also called edaravone deborbeol placebo
Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.

Study groups in NCT04667637
Study group	Role	What they receive
0.9% NaCl	Placebo comparator	Intravenous injections of 0.9% NaCl BID for 12 ±2days. Receives: Drug: edaravone dexborneol
Edaravone Dexborneol	Experimental	Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days. Receives: Drug: edaravone dexborneol

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with modified Rankin Score 0 to 2
Proportion of patients with modified Rankin Score 0 to 2
Measured: Day 90

Secondary outcomes (4)

Proportion of patients with modified Rankin Score 0 to 1
Proportion of patients with modified Rankin Score 0 to 1
Measured: Day 90
Distribution of modified Rankin Score
Distribution of modified Rankin Score after the treatment
Measured: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome
Measured: 24 hours, 48 hours, and 2 weeks
Change in infarct volume
infarct volume is determinted by CT or DWI
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202110 Oct 2022

First posted16 Dec 2020
Study start23 Feb 2021
Primary completion10 Oct 2022
Study completion10 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04667637
Sponsor's protocol ID: Y(2020)045
Status last verified: Oct 2022
First submitted: 8 Dec 2020
Last updated: 12 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Chen HS, Zhao ZA, Shen XY, Qiu SQ, Cui Y, Qiu J, Li W, Zhang H, Chen WH, Wang LH, Zhang DH, Chen Y, Ma YT, Gao ZE, Wang SC, Li D, Liu H, Nguyen TN. Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial. Nat Commun. 2025 Mar 10;16(1):2393. doi: 10.1038/s41467-025-57774-x.
PubMed 40064868

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study
ClinicalTrials.gov ID: NCT04667637
Acronym / sponsor ID: Y(2020)045
Conditions: Stroke, Endovascular Thrombectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Hui-Sheng ChenUniversity, hospital or other
Study start: 23 Feb 2021 (actual)
Primary completion: 10 Oct 2022 (actual)
Study completion: 10 Oct 2022 (actual)
First posted: 16 Dec 2020 (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.

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
0.9% NaCl	Placebo comparator	Drug: edaravone dexborneolIntravenous injections of 0.9% NaCl BID for 12 ±2days.
Edaravone Dexborneol	Experimental	Drug: edaravone dexborneolIntravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 to 80 years of age;
Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
Sufficient recanalization within 9 hours of stroke onset;
Sufficient recanalization （TICI 2b-3）;
Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;

Key exclusion criteria (10 listed)

Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）
Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;

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 dexborneolAlso: edaravone deborbeol placeboIntravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.	Drug	0.9% NaCl, Edaravone Dexborneol

Primary outcome

Proportion of patients with modified Rankin Score 0 to 2
Time frame: Day 90
Proportion of patients with modified Rankin Score 0 to 2

4 secondary outcomes

Proportion of patients with modified Rankin Score 0 to 1
Time frame: Day 90
Distribution of modified Rankin Score
Time frame: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours, 48 hours, and 2 weeks
Change in infarct volume
Time frame: 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Derived from this study: PubMed 40064868Chen HS, Zhao ZA, Shen XY, Qiu SQ, Cui Y, Qiu J, Li W, Zhang H, Chen WH, Wang LH, Zhang DH, Chen Y, Ma YT, Gao ZE, Wang SC, Li D, Liu H, Nguyen TN. Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial. Nat Commun. 2025 Mar 10;16(1):2393. doi: 10.1038/s41467-025-57774-x.
Individual participant dataSharing planned: Yes

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing edaravone dexborneol in people with Stroke and Endovascular Thrombectomy, run by Hui-Sheng Chen 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 12 Oct 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with modified Rankin Score 0 to 2 (time frame: Day 90). 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 NCT04667637, which also lists 1 linked publication.

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 12 Oct 2022.