RecruitingPhase 4NCT07119021

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

Sponsor

Ruijun Ji

Enrollment

300 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria4

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;

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Interventions

DRUGIntravenous 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.

DRUGIV 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.