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Effect of Early Emergency Department Administration of Sublingual Edaravone Dexborneol on Neurological Function Improvement in Acute Ischemic Stroke Patients Undergoing Reperfusion Therapy: the EARLY-AID trial

Effect of Early Emergency Department Administration of Sublingual Edaravone Dexborneol on Neurological Function Improvement in Acute Ischemic Stroke Patients Undergoing Reperfusion Therapy: the EARLY-AID trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117665
Enrollment
Unknown
Registered
2026-01-27
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

Reperfusion therapy+Sublingual Edaravone Dexborneol group :Sublingual Edaravone Dexborneol tablets (1 tablet bid 14 days)
Reperfusion therapy+placebo group:placebo (1 tablet bid 14 days)

Sponsors

Zigong Fourth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years old; 2. Modified Rankin Scale (mRS) score <=1 before the onset of this illness; 3. NIHSS <=25; 4. Time since onset <=4.5 hours and meets the criteria for intravenous thrombolysis; 5. Informed consent signed by family members.

Exclusion criteria

Exclusion criteria: 1. Has already used neuroprotective drugs after onset of illness; 2. Has contraindications to intravenous thrombolysis; 3. Patients who cannot cooperate with the use of edaravone dexborneol sublingual tablets for various reasons; 4. Patients with severe heart, liver, or kidney dysfunction; 5. Patients with diseases such as end-stage cancer or end-stage heart disease that interfere with clinical evaluation; 6. Pregnant or breastfeeding patients; 7. Patients who withdraw from the study midway; 8. Participants in other clinical studies; 9. Other situations deemed inappropriate for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with mRS score <=1 at 90 days;

Secondary

MeasureTime frame
Proportion of patients with mRS score <=2 at 90 days;Modified Rankin Scale (mRS) score on day 90 after randomization;change in NIHSS score from baseline to day 14;the proportion of patients with an NIHSS score of 1or less on day14, 30, and 90 after randomization;

Countries

China

Contacts

Public ContactYunbo Chen

Zigong Fourth People's Hospital

chenyunbo1978@hotmail.com+86 137 0815 3912

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026