Back to resultsEffect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke (EARLYS)
Primary Purpose
Ischemic Stroke, Acute, Treatment Outcome
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Edaravone Dexborneol Concentrated Solution for injection
Edaravone Dexborneol placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Acute ischemic stroke, Semi-dark band, Brain cell protection, Time window, Erafurone dextrol injection, Treatment Outcome
Eligibility Criteria
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.
Sites / Locations
- Brain Hospital of Hunan Province
- Hunan Provincial People's Hospital
- XiangYa School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Edaravone Dexborneol group
Edaravone Dexborneol Placebo group
Arm Description
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
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).
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
All-cause mortality
All-cause mortality at 90 days after randomization
Full Information
NCT ID
NCT05885919
First Posted
May 14, 2023
Last Updated
June 25, 2023
Sponsor
Xiangya Hospital of Central South University
Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05885919
Brief Title
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute, Treatment Outcome
Keywords
Acute ischemic stroke, Semi-dark band, Brain cell protection, Time window, Erafurone dextrol injection, Treatment Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects with AIS who met the criteria for inclusion were stratified 1:1 from onset to use of the investigational drug: early (< 3 hours) and late (3-6 hours).
Each layer was then randomly assigned to two groups in a 1:1 ratio: the right group and the placebo group.
Test group:
Edaravone dextronicol concentrated solution for injection, 15ml / time (37.5mg / time, of which edaravone 30mg, (+)-2-camphol 7.5mg), that is, 3 bottles / time, 2 times a day, for 12±2 days;
Control group:
Equal dose of placebo, 15 ml / time, that is, 3 sticks / time, 2 times a day for 12±2 days.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Edaravone Dexborneol group
Arm Type
Experimental
Arm Description
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Arm Title
Edaravone Dexborneol Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Intervention Type
Drug
Intervention Name(s)
Edaravone Dexborneol Concentrated Solution for injection
Other Intervention Name(s)
Xian Bi Xin,CFDA Approval Number H20200007
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Edaravone Dexborneol placebo
Other Intervention Name(s)
Xian Bi Xin placebo
Intervention Description
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Primary Outcome Measure Information:
Title
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
Description
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Neurological recovery
Description
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Time Frame
90 days
Title
Modified Rankin scale
Description
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).
Time Frame
90 days
Title
Quality of life score (EQ-5D)
Description
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Time Frame
90 days
Title
The incidence of serious adverse events
Description
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Time Frame
90 days
Title
All-cause mortality
Description
All-cause mortality at 90 days after randomization
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Le, PhD
Phone
13973187150
Email
zlzdzlzd@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li Ye, Master
Phone
17670516381
Email
17670516318@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Le, PhD
Organizational Affiliation
Department of Neurology，XiangYa School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Hospital of Hunan Province
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Kun, PhD
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
XiangYa School of Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Xiangbin
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33588596
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 Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
Results Reference
result
PubMed Identifier
34487721
Citation
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. Epub 2021 Sep 3.
Results Reference
result
Learn more about this trial
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
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