Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Tiantan Hospital of Capital Medical University
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.
Placebo_comparator: 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.