Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)

Ruijun Ji

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Stroke

Treatments: Drug: Intravenous thrombolysis + edaravone; Drug: IV thrombolysis + placebo (control group)

Study type: Interventional

Funder types: Other

Identifiers

NCT07119021

NS&T(2023ZD0503805) (Other Identifier)

2023ZD0503805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Intravenous thrombolysis + edaravone (intervention group)

Experimental group

Description:

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:

Drug: Intravenous thrombolysis + edaravone

IV thrombolysis + placebo (control group)

Placebo Comparator group

Description:

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.

Treatment:

Drug: IV thrombolysis + placebo (control group)