Stroke, IschemicPhase 2NCT05035953
Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke
A Phase 2 study testing Edaravone Dexborneol in people with Stroke, Ischemic, run by Huashan Hospital.
Trial summary
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis. 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?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2021to 13 Mar 2024
- 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
- Acute ischemic stroke;
- 18 to 80 years of age;
- There are clear signs of neurological deficit: 8≤NIHSS score≤24;
- Received alteplase thrombolysis therapy within 4.5 hours after onset;
- Patients signed written inform consent
Who cannot join
- Patients need endovascular therapy or bridge therapy;
- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months;
- Intracranial or intraspinal surgery within 3 months;
- Active visceral hemorrhage
- Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site;
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- Unknown onset time;
- Rapid improvement of symptoms or mild symptoms before thrombolysis therapy;
- A platelet count below 100,000/mm3 indicates a propensity for acute bleeding;
- Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Patients with severe mental disorders and dementia;
- ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
- Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
- Patients with malignant tumors or severe systemic disease;
- allergic to edaravone , (+)-Borneol or related excipients;
- Pregnant or lactating women;
- Have major surgery within 4 weeks before enrollment;
- Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
- The investigators consider the patients are not suitable for this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received thrombolysis.
- Conditions
- Stroke, Ischemic
- Being tested
- Edaravone Dexborneol, Placebo
- 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
Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis
PlaceboDrug
Edaravone Dexborneol matching injection, addition to thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| Edaravone | Experimental | Edaravone Dexborneol injection Receives: Drug: Edaravone Dexborneol |
| Placebo | Placebo comparator | Edaravone Dexborneol matching injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of symptomatic intracranial hemorrhage
Measured: 36-48 hours
Secondary outcomes (9)
The proportion of symptomatic intracranial hemorrhage
Measured: 7 days
The proportion of intracranial hemorrhage
Measured: 36-48 hours, 7 days
The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1
Measured: 90 days
The change in the NIH stroke scale (NIHSS) from the baseline
Measured: 36-48 hours, 7, 14 and 90 days
The proportion of Participants With Barthel Index (BI) score greater than or equal to 95
Measured: 14 and 90 days
Vascular recanalization
Measured: 36-48 hours
Blood Brain Barrier Permeability
Measured: 36-48 hours
Proportion of Encephaledema
Measured: 36-48 hours
Proportion of Death
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 posted5 Sep 2021
- Study start13 Sep 2021 (estimated)
- Primary completion13 Sep 2023 (estimated)
- Study completion13 Mar 2024 (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 Huashan HospitalThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Stroke Association
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035953
- Sponsor's protocol ID
- SMA-AIS-003
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05035953
- Acronym / sponsor ID
- SMA-AIS-003
- Conditions
- Stroke, Ischemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Stroke Association
- Study start
- 13 Sep 2021 (estimated)
- Primary completion
- 13 Sep 2023 (estimated)
- Study completion
- 13 Mar 2024 (estimated)
- First posted
- 5 Sep 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 the treatment of acute ischemic stroke patients who received thrombolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edaravone | Experimental | Drug: Edaravone DexborneolEdaravone Dexborneol injection |
| Placebo | Placebo comparator | Drug: PlaceboEdaravone Dexborneol matching injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute ischemic stroke;
- 18 to 80 years of age;
- There are clear signs of neurological deficit: 8≤NIHSS score≤24;
- Received alteplase thrombolysis therapy within 4.5 hours after onset;
- Patients signed written inform consent
Key exclusion criteria (19 listed)
- Patients need endovascular therapy or bridge therapy;
- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months;
- Intracranial or intraspinal surgery within 3 months;
- Active visceral hemorrhage
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 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis | Drug | Edaravone |
| PlaceboEdaravone Dexborneol matching injection, addition to thrombolysis | Drug | Placebo |
Primary outcome
The proportion of symptomatic intracranial hemorrhage
Time frame: 36-48 hours
9 secondary outcomes
The proportion of symptomatic intracranial hemorrhage
Time frame: 7 days
The proportion of intracranial hemorrhage
Time frame: 36-48 hours, 7 days
The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1
Time frame: 90 days
The change in the NIH stroke scale (NIHSS) from the baseline
Time frame: 36-48 hours, 7, 14 and 90 days
The proportion of Participants With Barthel Index (BI) score greater than or equal to 95
Time frame: 14 and 90 days
Vascular recanalization
Time frame: 36-48 hours
Blood Brain Barrier Permeability
Time frame: 36-48 hours
Proportion of Encephaledema
Time frame: 36-48 hours
Proportion of Death
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 5 Sep 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edaravone Dexborneol in people with Stroke, Ischemic, run by Huashan Hospital.
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 19 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Dong (86-21-52887142, qiang_dong163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of symptomatic intracranial hemorrhage (time frame: 36-48 hours). 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 5 Sep 2021.