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

Ischemic Stroke, Acute Clinical Trial

— EARLYS  

Official title:

Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke-A Multicenter, Randomized, Double-blind, Placebo-controlled, Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885919
• Other study ID #: Shenjingneike
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Xiangya Hospital of Central South University
• Contact: Zhang Le, PhD
• Phone: 13973187150
• Email: zlzdzlzd[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 212
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke
• Treatment Outcome

Intervention

Drug:
• Edaravone Dexborneol Concentrated Solution for injection
Edaravone and Dexborneol Concentrated Solution for Injection, 15 ml (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) in 3 ampoule bottles, twice a day for 10 to 14 days.
• Edaravone Dexborneol placebo
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.

Locations

Country	Name	City	State
China	Brain Hospital of Hunan Province	Changsha	Hunan
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	XiangYa School of Medicine	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (2)

GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. — View Citation

Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke	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	90 days
Secondary	Neurological recovery	The difference value of the NIHSS between Day 14/Day 90 and the baseline.	90 days
Secondary	Modified Rankin scale	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).	90 days
Secondary	Quality of life score (EQ-5D)	Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.	90 days
Secondary	The incidence of serious adverse events	The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.	90 days
Secondary	All-cause mortality	All-cause mortality at 90 days after randomization	90 days