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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Primary endpoint indicators [Срок оценки: From the start of revascularization until 72 hours after treatment.]

Вторичные конечные точки (1)

• Secondary endpoint indicators [Срок оценки: 90 days after onset of illness]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital of Capital Medical University — Пекин

Идентификаторы

NCT: NCT07119021 · 2023ZD0503805 · NS&T(2023ZD0503805)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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