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Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke (SLEDAIS)
Sponsor: Xinqiao Hospital of Chongqing
Summary
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.
Official title: Efficacy and Safety of Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1040
Start Date
2026-07-01
Completion Date
2028-09-30
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Edaravone dexborneol sublingual tablet
Edaravone Dexborneol is a novel neuroprotective agent combining edaravone (a free radical scavenger) and dexborneol (an anti-inflammatory component) in a 5:1 ratio. In this study, participants in the experimental group will receive a loading dose of 4 sublingual tablets (each containing edaravone 30mg + dexborneol 6mg, total: edaravone 120mg + dexborneol 24mg) within 10 minutes after randomization during inter-hospital transfer. From day 2 to day 14, participants will receive 1 tablet twice daily. The sublingual formulation dissolves within 5 minutes, allowing rapid absorption through the sublingual venous plexus and bypassing hepatic first-pass effect. This high initial loading dose aims to rapidly establish therapeutic concentrations before endovascular therapy to provide neuroprotection during the critical transfer window.
Placebo
Matching placebo sublingual tablets identical in appearance, smell, and packaging to the active drug. Participants will receive a loading dose of 4 placebo tablets (each containing 60μg dexborneol, a trace amount solely for maintaining blinding with no expected therapeutic effect) within 10 minutes after randomization. From day 2 to day 14, participants will receive 1 placebo tablet twice daily. The placebo is designed to be indistinguishable from Edaravone Dexborneol tablets to maintain the double-blind design.
Locations (1)
Xinqiao Hospital and The Second Affiliated Hospital
Chongqing, Chongqing Municipality, China