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

NCT07119021 | Recruiting Phase 4 DMC

• 2 other identifiers: 2023ZD0503805NS&T(2023ZD0503805)
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Ischemic Stroke

Keywords

Acute Ischemic Stroke; Bleeding Conversion; Edaravone Sublingual Tablets

Outcome Measures

Primary Outcomes (1)

• Primary endpoint indicators

  Proportion of patients with transformed bleeding on MRI at 72 hours after revascularization.

  From the start of revascularization until 72 hours after treatment.

Secondary Outcomes (1)

• Secondary endpoint indicators

  90 days after onset of illness

Study Arms (2)

Intravenous thrombolysis + edaravone (intervention group)

EXPERIMENTAL

The patient underwent intravenous t-PA thrombolysis and sublingual administration of edaravone tablets in the prehospital ambulance. The method of intravenous t-PA thrombolysis is in accordance with the international guidelines: 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 uniform rate within one hour.

Drug: Intravenous thrombolysis + edaravone

IV thrombolysis + placebo (control group)

PLACEBO COMPARATOR

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.

Drug: IV thrombolysis + placebo (control group)

Interventions

Intravenous thrombolysis + edaravone DRUG

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.

Intravenous thrombolysis + edaravone (intervention group)

IV thrombolysis + placebo (control group) DRUG

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.

IV thrombolysis + placebo (control group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Acute ischemic stroke as defined by the International Health Organization (WHO) and confirmed by cranial CT;
• Onset within a 4.5-hour time window;
• NIHSS score of 6-24;
• Meet the criteria for intravenous thrombolysis in acute ischemic stroke recommended by international guidelines;
• Patient or family consent.

You may not qualify if:

• Pregnant women, women in labor, and patients in the puerperium;
• Comorbidity with other serious diseases that affect outcome determination;
• Comorbidity with other serious diseases that affect prognostic regression;
• Comorbidity with other serious diseases with a life expectancy of less than 1 year;

Sponsors & Collaborators

• Ruijun Ji: lead
• Xing'an League People's Hospital: collaborator
• Suzhou First People's Hospital: collaborator
• Nanyang nanshi Hospital: collaborator
• Nanjing Baixinyu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital of Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Edaravone; Fibrinolytic Agents; Control Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician/Professor

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)