Ischemic StrokePhase 4EXCELLENTNCT07119021
Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
A Phase 4 study testing Intravenous thrombolysis + edaravone in people with Ischemic Stroke, run by Ruijun Ji at 1 site in China.
Trial summary
EXCELLENT was a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study in which participants were randomized participants were randomized (1:1) to receive either IV thrombolysis + edaravone or IV thrombolysis + matched placebo (same volume of tablets without drug components), and the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Intravenous thrombolysis + edaravone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age 18-80 years;
- Acute ischemic stroke as defined by the International Health Organization (WHO) and confirmed by cranial CT;
- Onset within a 4.5-hour time window;
- NIHSS score of 6-24;
- Meet the criteria for intravenous thrombolysis in acute ischemic stroke recommended by international guidelines;
- Patient or family consent.
Who cannot join
- Pregnant women, women in labor, and patients in the puerperium;
- Comorbidity with other serious diseases that affect outcome determination;
- Comorbidity with other serious diseases that affect prognostic regression;
- Comorbidity with other serious diseases with a life expectancy of less than 1 year;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital of Capital Medical University
Beijing
ruijun Ji ruijun Ji, 18611589856, jrjchina@sina.com
About this study
EXCELLENT was a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study in which participants were randomized participants were randomized (1:1) to receive either IV thrombolysis + edaravone or IV thrombolysis + matched placebo (same volume of tablets without drug components), and the primary outcome was the proportion of patients with transformed bleeding on MRI at 72 hours following revascularization therapy.
Read the detailed description
- Study on the effectiveness of neuroprotection combined with revascularization in the treatment of acute ischemic stroke in the ultra-early mobile stroke unit (MSU): Based on the MSU model, using the RCT study design, for patients with disabling AIS within 4.5h, patients were randomly assigned 1:1 to the experimental group and the control group and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main evaluation index was the proportion of patients with transformed blood flow on MRI at 72 hours after receiving recanalization, and the other indexes included the patients' 90-day onset The remaining indicators include the modified Rankin Scale (mRS) score (hierarchical data), the proportion of patients with an mRS score of <1 at 90 days of onset, the proportion of patients with an mRS score of <2 at 90 days of onset, the time from onset to intravenous thrombolysis (in minutes), and the proportion of patients who received intravenous thrombolysis within 60 minutes of onset.
- Safety study of ultra-early mobile stroke unit neuroprotection combined with revascularization for acute ischemic stroke:
Based on the MSU model, using the RCT study design for patients with disabling AIS within 4.5h, patients were 1:1 randomly assigned to the experimental group and control group, and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main safety evaluation indexes included all deaths during hospitalization, hospitalized deaths after receiving intravenous thrombolysis, deaths at 3 months after stroke, deaths at 3 months after receiving intravenous thrombolysis, and the proportion of symptomatic intracranial hemorrhage within 36 hours of the onset of the disease, and so on.
- Conditions
- Ischemic Stroke
- Being tested
- Intravenous thrombolysis + edaravone, IV thrombolysis + placebo (control group)
- Keywords
- Acute Ischemic Stroke, Bleeding Conversion, Edaravone Sublingual Tablets
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous thrombolysis + edaravoneDrug
The patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. Intravenous t-PA thrombolysis was performed in accordance with international guidelines: t-PA dose was calculated according to 0.9mg/kg; 10% of the total dose was injected intravenously, and the remaining 90% was administered intravenously at a uniform rate within one hour.
IV thrombolysis + placebo (control group)Drug
Patients underwent intravenous t-PA thrombolysis + placebo sublingual administration. The method of intravenous t-PA thrombolysis is in accordance with the international guideline standards: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a constant rate within 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous thrombolysis + edaravone (intervention group) | Experimental | The patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. The method of intravenous t-PA thrombolysis is in accordance with the international guidelines: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a uniform rate within one hour. Receives: Drug: Intravenous thrombolysis + edaravone |
| IV thrombolysis + placebo (control group) | Placebo comparator | Patients underwent intravenous t-PA thrombolysis + placebo sublingual administration. The method of intravenous t-PA thrombolysis is in accordance with the international guideline standards: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a constant rate within 1 hour. Receives: Drug: IV thrombolysis + placebo (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint indicators
Proportion of patients with transformed bleeding on MRI at 72 hours after revascularization.
Measured: From the start of revascularization until 72 hours after treatment.
Secondary outcomes (1)
Secondary endpoint indicators
- Patients' modified Rankin Scale (mRS) scores at 90 days after onset of illness (hierarchical data). (i) Proportion of patients with mRS score <1 at 90 days of disease onset; (ii) Proportion of patients with mRS score <2 at 90 days of presentation;
- Time from onset to intravenous thrombolytic therapy (in minutes);
- Proportion of patients receiving intravenous thrombolytic therapy within 60 minutes of onset;
- Proportion of patients receiving subsequent endovascular treatment;
- Time from onset to femoral artery puncture (minutes);
Measured: 90 days after onset of illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Aug 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijun Ji
- Sponsor type
- University, hospital or other
- Collaborators
- Xing'an League People's Hospital, The First Affiliated Hospital of Soochow University, Nanyang Nanshi Hospital, Nanjing Baixinyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Ruijun Ji, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119021
- Sponsor's protocol ID
- 2023ZD0503805
- Other IDs
- NS&T(2023ZD0503805)
- Acronym
- EXCELLENT
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
- ClinicalTrials.gov ID
- NCT07119021
- Acronym / sponsor ID
- EXCELLENT / 2023ZD0503805
- Conditions
- Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Bleeding Conversion, Edaravone Sublingual Tablets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijun JiUniversity, hospital or other
- Collaborators
- Xing'an League People's Hospital, The First Affiliated Hospital of Soochow University, Nanyang Nanshi Hospital, Nanjing Baixinyu Pharmaceutical Co., Ltd.
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
EXCELLENT was a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study in which participants were randomized participants were randomized (1:1) to receive either IV thrombolysis + edaravone or IV thrombolysis + matched placebo (same volume of tablets without drug components), and the primary outcome was the proportion of patients with transformed bleeding on MRI at 72 hours following revascularization therapy.
Detailed description
- Study on the effectiveness of neuroprotection combined with revascularization in the treatment of acute ischemic stroke in the ultra-early mobile stroke unit (MSU): Based on the MSU model, using the RCT study design, for patients with disabling AIS within 4.5h, patients were randomly assigned 1:1 to the experimental group and the control group and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main evaluation index was the proportion of patients with transformed blood flow on MRI at 72 hours after receiving recanalization, and the other indexes included the patients' 90-day onset The remaining indicators include the modified Rankin Scale (mRS) score (hierarchical data), the proportion of patients with an mRS score of <1 at 90 days of onset, the proportion of patients with an mRS score of <2 at 90 days of onset, the time from onset to intravenous thrombolysis (in minutes), and the proportion of patients who received intravenous thrombolysis within 60 minutes of onset.
- Safety study of ultra-early mobile stroke unit neuroprotection combined with revascularization for acute ischemic stroke:
Based on the MSU model, using the RCT study design for patients with disabling AIS within 4.5h, patients were 1:1 randomly assigned to the experimental group and control group, and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main safety evaluation indexes included all deaths during hospitalization, hospitalized deaths after receiving intravenous thrombolysis, deaths at 3 months after stroke, deaths at 3 months after receiving intravenous thrombolysis, and the proportion of symptomatic intracranial hemorrhage within 36 hours of the onset of the disease, and so on.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous thrombolysis + edaravone (intervention group) | Experimental | Drug: Intravenous thrombolysis + edaravoneThe patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. The method of intravenous t-PA thrombolysis is in accordance with the international guidelines: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a uniform rate within one hour. |
| IV thrombolysis + placebo (control group) | Placebo comparator | Drug: IV thrombolysis + placebo (control group)Patients underwent intravenous t-PA thrombolysis + placebo sublingual administration. The method of intravenous t-PA thrombolysis is in accordance with the international guideline standards: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a constant rate within 1 hour. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years;
- Acute ischemic stroke as defined by the International Health Organization (WHO) and confirmed by cranial CT;
- Onset within a 4.5-hour time window;
- NIHSS score of 6-24;
- Meet the criteria for intravenous thrombolysis in acute ischemic stroke recommended by international guidelines;
Key exclusion criteria (4 listed)
- Pregnant women, women in labor, and patients in the puerperium;
- Comorbidity with other serious diseases that affect outcome determination;
- Comorbidity with other serious diseases that affect prognostic regression;
- Comorbidity with other serious diseases with a life expectancy of less than 1 year;
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 |
|---|---|---|
| Intravenous thrombolysis + edaravoneThe patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. Intravenous t-PA thrombolysis was performed in accordance with international guidelines: t-PA dose was calculated according to 0.9mg/kg; 10% of the total dose was injected intravenously, and the remaining 90% was administered intravenously at a uniform rate within one hour. | Drug | Intravenous thrombolysis + edaravone (intervention group) |
| IV thrombolysis + placebo (control group)Patients underwent intravenous t-PA thrombolysis + placebo sublingual administration. The method of intravenous t-PA thrombolysis is in accordance with the international guideline standards: t-PA dose is calculated according to 0.9mg/kg; 10% of the total dose is injected intravenously, and the remaining 90% is administered intravenously at a constant rate within 1 hour. | Drug | IV thrombolysis + placebo (control group) |
Primary outcome
Primary endpoint indicators
Time frame: From the start of revascularization until 72 hours after treatment.
Proportion of patients with transformed bleeding on MRI at 72 hours after revascularization.
1 secondary outcome
Secondary endpoint indicators
Time frame: 90 days after onset of illness
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous thrombolysis + edaravone in people with Ischemic Stroke, run by Ruijun Ji 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 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Primary endpoint indicators (time frame: From the start of revascularization until 72 hours after treatment.). 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 12 Aug 2025.