Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
EARLYS
1 other identifier
interventional
212
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 27, 2023
April 1, 2023
1.5 years
May 14, 2023
June 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Neurological recovery
90 days
Modified Rankin scale
90 days
Quality of life score (EQ-5D)
90 days
The incidence of serious adverse events
90 days
All-cause mortality
90 days
Study Arms (2)
Edaravone Dexborneol group
EXPERIMENTALPatients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Edaravone Dexborneol Placebo group
PLACEBO COMPARATORPatients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Interventions
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 and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brain Hospital of Hunan Province
Changsha, Hunan, 410008, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410008, China
XiangYa School of Medicine
Changsha, Hunan, 410008, China
Related Publications (2)
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.
PMID: 33588596RESULTGBD 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.
PMID: 34487721RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Le, PhD
Department of Neurology，XiangYa School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2023
First Posted
June 2, 2023
Study Start
July 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 27, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share