Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous thrombolysis + edaravone, IV thrombolysis + placebo (control group).
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
1. 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. 2. 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.
Interventions
- Drug Intravenous thrombolysis + edaravone
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. - 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.
Primary outcome measures
- Primary endpoint indicators [Time frame: From the start of revascularization until 72 hours after treatment.]
Secondary outcome measures (1)
- Secondary endpoint indicators [Time frame: 90 days after onset of illness]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing Tiantan Hospital of Capital Medical University — Beijing
Identifiers
NCT: NCT07119021 · 2023ZD0503805 · NS&T(2023ZD0503805)