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

NCT ID: NCT07119021

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-07-31

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.

Detailed Description

1. Study on the effectiveness of neuroprotection combined with revascularization in the treatment of acute ischemic stroke in the ultra-early mobile stroke unit (MSU):

Based on the MSU model, using the RCT study design, for patients with disabling AIS within 4.5h, patients were randomly assigned 1:1 to the experimental group and the control group and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main evaluation index was the proportion of patients with transformed blood flow on MRI at 72 hours after receiving recanalization, and the other indexes included the patients' 90-day onset The remaining indicators include the modified Rankin Scale (mRS) score (hierarchical data), the proportion of patients with an mRS score of <1 at 90 days of onset, the proportion of patients with an mRS score of <2 at 90 days of onset, the time from onset to intravenous thrombolysis (in minutes), and the proportion of patients who received intravenous thrombolysis within 60 minutes of onset.

2. Safety study of ultra-early mobile stroke unit neuroprotection combined with revascularization for acute ischemic stroke:

Based on the MSU model, using the RCT study design for patients with disabling AIS within 4.5h, patients were 1:1 randomly assigned to the experimental group and control group, and were given the neuroprotective agent edaravone tablets + intravenous thrombolysis and placebo + intravenous thrombolysis interventions, respectively. The main safety evaluation indexes included all deaths during hospitalization, hospitalized deaths after receiving intravenous thrombolysis, deaths at 3 months after stroke, deaths at 3 months after receiving intravenous thrombolysis, and the proportion of symptomatic intracranial hemorrhage within 36 hours of the onset of the disease, and so on.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous thrombolysis + edaravone (intervention group)

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.

Group Type: EXPERIMENTAL

Intravenous thrombolysis + edaravone

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

IV thrombolysis + placebo (control group)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xing'an League People's Hospital

UNKNOWN

Sponsor Role: collaborator

Suzhou First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Nanyang nanshi Hospital

UNKNOWN

Sponsor Role: collaborator

Nanjing Baixinyu Pharmaceutical Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Ruijun Ji

OTHER

Sponsor Role: lead

Responsible Party

Ruijun Ji

Chief Physician/Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Tiantan Hospital of Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

ruijun Ji ruijun Ji

Role: primary

jrjchina@sina.com

18611589856

Other Identifiers

NS&T(2023ZD0503805)

Identifier Type: OTHER

Identifier Source: secondary_id

2023ZD0503805

Identifier Type: -

Identifier Source: org_study_id