Ultra-early Mobile Stroke Unit neuroprotection combined with revascularization for acute ischemic stroke
Official title: Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
Run by Beijing Tiantan Hospital · NCT07119021 · Data updated 2026-11-12
This trial tests whether giving edaravone tablets together with IV thrombolysis in an ultra-early mobile stroke unit can reduce bleeding on brain MRI and improve recovery for adults with disabling ischemic stroke treated within 4.5 hours of symptom onset.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | April 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT07119021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–80 with confirmed acute ischemic stroke, disabling symptoms, NIHSS 6–24, who present and can be treated within 4.5 hours and meet standard IV thrombolysis criteria.
✕Probably not a fit
Patients outside the 4.5-hour window, with hemorrhagic stroke, pregnant or postpartum women, those with severe comorbidities or limited life expectancy, or who do not meet thrombolysis criteria are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial that enrolled adults with disabling acute ischemic stroke within 4.5 hours and NIHSS 6–24. Participants were randomized 1:1 to receive IV thrombolysis plus sublingual edaravone tablets or IV thrombolysis plus matched placebo in the mobile stroke unit setting. The primary outcome was the proportion of patients with hemorrhagic transformation on MRI at 72 hours after reperfusion, and secondary outcomes included 90-day functional outcomes (mRS), rates of excellent recovery (mRS <1 and <2), and time metrics for thrombolysis. Safety endpoints included adverse events related to the neuroprotective agent and hemorrhagic complications following revascularization.
Why it matters
Potential benefit: If successful, adding edaravone to ultra-early thrombolysis could lower rates of hemorrhagic transformation and improve 90-day functional recovery for selected patients.
How similar studies have gone: Edaravone has been used as a neuroprotective agent in prior stroke studies with some positive signals, but its added benefit when given ultra-early in a mobile stroke unit alongside thrombolysis has not been definitively proven and this RCT design is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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;
Where it's running
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Beijing Tiantan Hospital of Capital Medical University
Beijing, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.