NCT07119021 Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
| NCT ID | NCT07119021 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ruijun Ji |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2024-08-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 primary outcome was the proportion of patients with transformed bleeding on MRI at 72 hours following revascularization therapy.
Eligibility 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;
Frequently Asked Questions
Who can join the NCT07119021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07119021 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07119021 currently recruiting?
Yes, NCT07119021 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijun Ji to inquire about joining.
Where is the NCT07119021 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07119021 clinical trial?
NCT07119021 is sponsored by Ruijun Ji. The trial plans to enroll 300 participants.
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