Tests edaravone with clot-busting drug treatment for acute ischemic stroke
Tests edaravone added to clot-busting treatment in adults with a sudden ischemic stroke.
Key facts
- Who runs it
- Ruijun Ji
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 300 people, planned
- Started
- 1 Aug 2024
- Expected to end
- 31 Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Intravenous thrombolysis + edaravone
- IV thrombolysis + placebo (control group)
- Record updated
- 12 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 who had an acute ischemic stroke within the last 4.5 hours and can receive clot-dissolving treatment into a vein.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke confirmed by head CT, with symptoms starting within 4.5 hours and an NIHSS score of 6-24.
- Earlier treatment
- Must meet the international guideline criteria for intravenous thrombolysis (clot-dissolving treatment given into a vein).
Main reasons for not taking part
- Pregnant women, women in labor, and women after childbirth (puerperium)
- Other serious diseases that affect how the outcome is judged
- Other serious diseases that affect recovery
- Other serious disease with a life expectancy of less than 1 year
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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
- Pregnant women, women in labor, and patients in the puerperium
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Beijing Tiantan Hospital of Capital Medical UniversityBeijing, ChinaContact: ruijun Ji ruijun JiTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intravenous thrombolysis + edaravone (intervention group)Treatment being tested
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.
Treatment: Intravenous thrombolysis + edaravone
- IV thrombolysis + placebo (control group)Placebo, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
- Plain-language title
- Tests edaravone with clot-busting drug treatment for acute ischemic strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07119021, who can take part
- Record updated
- 12 August 2025