A Phase 4 interventional study of Edaravone dexborneol sublingual tablet and Placebo in Acute Ischemic Stroke, sponsored by Xinqiao Hospital of Chongqing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Xinqiao Hospital of Chongqing · Phase 4, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,040 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Edaravone dexborneol sublingual tablet
Drug: Placebo
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.
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.
Modified Rankin Scale (mRS) Score at 90 Days
Functional outcome assessed by the modified Rankin Scale (mRS) at 90 days post-randomization. The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death), used to evaluate the degree of disability or dependence in daily activities.
Time frame: 90 days
Mortality Rate at 90 Days
All-cause mortality rate within 90 days post-randomization.
Time frame: 90 days
Infarct Volume at 36 Hours
Infarct volume (ml) measured by non-contrast CT or MRI-DWI at 36 hours post-procedure.
Time frame: 36 hours
NIHSS Score at Discharge
National Institutes of Health Stroke Scale (NIHSS) score assessed at 5-7 days or at hospital discharge, whichever comes first.
Time frame: 5-7 days or discharge
Proportion of Patients With mRS 0-1 at 90 Days
Percentage of patients achieving excellent functional outcome (mRS score 0-1, indicating no symptoms or symptoms but no disability) at 90 days.
Time frame: 90 days
Proportion of Patients With mRS 0-2 at 90 Days
Percentage of patients achieving functional independence (mRS score 0-2, indicating no to mild disability but able to care for self) at 90 days.
Time frame: 90 days
EQ-5D-5L Score at 90 Days
Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire at 90 days.
Time frame: 90 days
Incidence of Symptomatic Intracranial Hemorrhage at 36 Hours
Incidence of symptomatic intracranial hemorrhage (sICH) assessed by Heidelberg criteria at 36 hours post-procedure.
Time frame: 36 hours
Incidence of Any Intracranial Hemorrhage at 36 Hours
Proportion of patients with any type of intracranial hemorrhage (including hemorrhagic infarction and parenchymal hematoma) at 36 hours.
Time frame: 36 hours
Incidence of Non-Intracranial Hemorrhage Complications
Incidence of non-intracranial bleeding complications within 90 days, including gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.
Time frame: 90 days
Incidence of Non-Hemorrhagic Serious Adverse Events
Incidence of non-hemorrhagic serious adverse events (SAEs) within 90 days.
Time frame: 90 days
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jul 2028, 24 months later.
Of 74 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 24 months is below that.
Counting every sponsor, half of 83 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Xinqiao Hospital of Chongqing