Stroke, IschemicPhase 2EXISTENTNCT04817527
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows
A Phase 2 study testing Edaravone Dexborneol in people with Stroke, Ischemic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Edaravone Dexborneol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 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;
- Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI <31ml or with a NIHSS ≥20 and 31ml<Volume of infarction<51ml(DWI);
- Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
- Endovascular Therapy in 6-24 hours of stroke onset;
- The availability of informed consent.
Who cannot join
- First ever stroke or mRS≤1 after previous disease;
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
- 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 cardiac or pulmonary disease;
- Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
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- 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, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Jianfeng Han, MD
About this study
Official title: Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
- Conditions
- Stroke, Ischemic
- Being tested
- Edaravone Dexborneol
- Keywords
- Endovascular therapy, Extended Time Windows
- 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 injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
| Study group | Role | What they receive |
|---|---|---|
| Edaravone Dexborneol | Experimental | Not described Receives: Drug: Edaravone Dexborneol |
| conventional therapy | No intervention | conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy |
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 3 on day 90
Measured: 90 days
Proportion of symptomatic intracranial hemorrhage (sICH)
Measured: 48 hours
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
Measured: 90 days
Secondary outcomes (11)
Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
Measured: 14 days
Distribution of modified Rankin Score after the treatment
Measured: 90 days
Change in infarct volume
Measured: 7 days
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Measured: 90 days
Activity of Daily Living Scale(ADL) score on day 14, 30, 90
Measured: 90 days
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Measured: 90 days
Serum inflammatory factors changes on day 1 and day 7
Measured: 7 days
Proportion of PH1 and PH2 within 48 hours after the treatment
Measured: 48 hours
Midline shift on the CT scan
Measured: 7 days
Proportion of death due to any cause
Measured: 90 days
Proportion of Serious adverse events(SAE)
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 posted26 Mar 2021
- Study start1 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817527
- Sponsor's protocol ID
- XJTU1AF2021LSK-065
- Acronym
- EXISTENT
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2021
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study
- ClinicalTrials.gov ID
- NCT04817527
- Acronym / sponsor ID
- EXISTENT / XJTU1AF2021LSK-065
- Conditions
- Stroke, Ischemic
- Keywords
- Endovascular therapy, Extended Time Windows
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 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.
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edaravone Dexborneol | Experimental | Drug: Edaravone Dexborneol |
| conventional therapy | No intervention | –conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 80 years of age;
- Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI <31ml or with a NIHSS ≥20 and 31ml<Volume of infarction<51ml(DWI);
- Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
- Endovascular Therapy in 6-24 hours of stroke onset;
- The availability of informed consent.
Key exclusion criteria (9 listed)
- First ever stroke or mRS≤1 after previous disease;
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
- 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 cardiac or pulmonary disease;
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 injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days. | Drug | Edaravone Dexborneol |
Primary outcome
Proportion of patients with modified Rankin Score 0 to 3 on day 90
Time frame: 90 days
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 48 hours
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
Time frame: 90 days
11 secondary outcomes
Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
Time frame: 14 days
Distribution of modified Rankin Score after the treatment
Time frame: 90 days
Change in infarct volume
Time frame: 7 days
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Time frame: 90 days
Activity of Daily Living Scale(ADL) score on day 14, 30, 90
Time frame: 90 days
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Time frame: 90 days
Serum inflammatory factors changes on day 1 and day 7
Time frame: 7 days
Proportion of PH1 and PH2 within 48 hours after the treatment
Time frame: 48 hours
Midline shift on the CT scan
Time frame: 7 days
Proportion of death due to any cause
Time frame: 90 days
Proportion of Serious adverse events(SAE)
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 1 Apr 2022.
- 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?
A Phase 2 study testing Edaravone Dexborneol in people with Stroke, Ischemic, run by First Affiliated Hospital Xi'an Jiaotong University 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 9 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 1 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Han, MD (+8618991232708, rabbit1110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Score 0 to 3 on day 90 (time frame: 90 days). The study lists 3 primary outcomes in all. 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 1 Apr 2022.