This is a multicenter, randomized, double-blind, placebo-controlled clinical trial (SLEDAIS) involving 1,040 patients with acute ischemic stroke (AIS) who require inter-hospital transfer for potential endovascular therapy. The study aims to evaluate the efficacy and safety of sublingual Edaravone Dexborneol tablets administered in the ultra-early stage (within 6 hours of symptom onset) during the critical inter-hospital transfer window.
Patients will be randomly assigned in a 1:1 ratio to receive either sublingual Edaravone Dexborneol (a loading dose of 4 tablets initially, followed by 1 tablet twice daily for 13 days) or a matching placebo. The primary efficacy endpoint is the functional outcome assessed by the modified Rankin Scale (mRS) score at 90 days. The primary safety endpoint is the mortality rate at 90 days. This study seeks to provide high-quality evidence for neuroprotection during the transfer period, potentially improving functional recovery for stroke patients.
Aged 18 to 80 years (inclusive).
Time from last known normal to arrival at the first hospital is within 6 hours.
Clinical and imaging diagnosis of acute ischemic stroke, with a Los Angeles Motor Scale (LAMS) score ≥ 4, or occlusion of the internal carotid artery, M1/M2 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery confirmed by CTA/MRA at the first or target hospital.
ASPECTS score ≥ 6 on non-contrast head CT at the first hospital.
Allergy to contrast agents, nickel, titanium, or their alloys.
Known allergy to dexborneol, edaravone, or excipients.
Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
Patients receiving intravenous thrombolysis alone.
Xinqiao Hospital of Chongqing
Lead sponsor
Simcere Pharmaceutical Group Co., LTD
Collaborator