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Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)

NCT07119021 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Intravenous thrombolysis + edaravone

The patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. Intravenous t-PA thrombolysis was performed in accordance with international guidelines: t-PA dose was calculated according to 0.9mg/kg; 10% of the total dose was injected intravenously, and the remaining 90% was administered intravenously at a uniform rate within one hour.

DRUG

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.

Sponsors & Collaborators

  • Xing'an League People's Hospital

    collaborator UNKNOWN

  • Suzhou First People's Hospital

    collaborator UNKNOWN

  • Nanyang nanshi Hospital

    collaborator UNKNOWN

  • Nanjing Baixinyu Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Ruijun Ji

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119021 on ClinicalTrials.gov