Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke

Phase 3

Not yet recruiting

• Conditions: Treatment Outcome; Ischemic Stroke, Acute
• Interventions: Drug: Edaravone Dexborneol placebo; Drug: Edaravone Dexborneol Concentrated Solution for injection

• Registration Number: NCT05885919
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

The primary objective of this study was to evaluate the efficacy and safety of initiation of edaravone dextivel therapy compared with placebo in patients with acute ischaemic stroke (early and late) and to explore the optimal time window for "brain cell protective therapy" of edaravone dexborneol.

Detailed Description

This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of (early and late) initiation treatment of Edaravone Dexborneol versus placebo in patients with acute ischemic stroke, and to explore the optimal time window for "brain cell protective therapy" of Edaravone Dexborneol. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be stratified by time to trial drug: early (\<3 hours) and late (3-6 hours). Then each layer will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15ml edaravone and dexborneol concentrated solution for injection (37.5mg, containing edaravone 30mg and dexborneol 7.5mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Study Start: 2023-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Age 18-80 years old, gender is not limited;
• Clinically confirmed acute ischemic stroke;
• Within 6 hours of the onset of this stroke;
• NIHSS score of 4-24 at enrollment;
• mRS score before onset≤ 1 point;
• Subject and subject's agent are able and willing to sign informed consent.

Exclusion Criteria

• CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
• Previously known severe liver or kidney insufficiency (ALT or AST is greater than 3.0×ULN; serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or dialysis;
• Systolic blood pressure≥220 mmHg or <90mmHg；
• Recent stroke within prior 1 month；
• Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
• Prior receipt of edaravone or any other neuroprotective drugs;
• History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.;
• Pregnancy, lactation, or planned pregnancy within 90 days;
• Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
• Those with a malignant tumor, severe systemic diseases, or predict survival time <90 days;
• Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study;
• The investigators consider the patients are not suitable for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edaravone Dexborneol Placebo group	Edaravone Dexborneol placebo	Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Edaravone Dexborneol group	Edaravone Dexborneol Concentrated Solution for injection	Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.

Primary Outcome Measures

Name	Time	Method
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke	90 days	To assess the proportion of participants (early and late) who started edaravone dextrol compared with placebo with a 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke

Secondary Outcome Measures

Name	Time	Method
Neurological recovery	90 days	The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Modified Rankin scale	90 days	used to evaluate the functional outcomes after AIS，good prognosis (mRS score 0-2), generally good prognosis (mRS score 3-4) , Poor prognosis (mRS \>4 points).
Quality of life score (EQ-5D)	90 days	Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
The incidence of serious adverse events	90 days	The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
All-cause mortality	90 days	All-cause mortality at 90 days after randomization

Trial Locations

Locations (3)

XiangYa School of Medicine; 🇨🇳 Changsha, Hunan, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

Brain Hospital of Hunan Province; 🇨🇳 Changsha, Hunan, China