Evaluating the efficacy of high-dose edaravone (Alsava) administered within the first 48 hours of hospitalization on short-term outcomes (NIHSS score) and long-term outcomes (MRS score) in patients with acute ischemic stroke eligible for Altylase(rTPA) therapy, admitted within 4.5 hours of symptom onset.
This study aims to evaluate the efficacy of ALSAVA (edaravone) in acute ischemic stroke patients eligible for intravenous thrombolysis, admitted within 4.5 hours of symptom onset, using NIHSS and MRS scores.
Design
The phase 2 clinical trial includes a control group and parallel groups, using a double-blind, randomized design with 60 patients. Randomization is conducted with blocks in Excel.
Settings and conduct
This study will occure at the Neurology Research Center of Imam Khomeini Hospital.
Group A: In addition to receiving routine altilase treatment (biosimilar retplase from Arena Hayat Danesh Company), 2 vials of Alsava (20 mg/30 cc, biosimilar Edaravon from Zist Daro Danesh Company), diluted in 160 cc of normal saline and infused over 1 hr. Alsava will be administered every 12 hours for 48 hrs.
Group B: In addition to the standard altilase treatment, a placebo of equal volume to Edaravone is given every 12 hrs for 48 hrs.
the patient and researcher are blinded to treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patient or surrogate consent is required.
age over 20.
NIHSS > 3 or < 4 with a debilitating disorder.
rTPA administration within 4.5 hr of symptom onset
Exclusion Criteria:
History of brain mass, stroke, head trauma, brain surgery, and seizures.
Severe neurological and systemic disorders result in pre-admission MRS scores above 0.
Liver and kidney failure.
Decompensated heart failure limits venous fluid volume for the study.
History of Allergies to Drugs and Non-Drugs
Sulfite allergy Hx.
Pregnant individuals
Patients eligible for mechanical thrombectomy.
Intervention groups
Alsava group will receive Alsava (edaravone) with standard treatment of reteplase.
control group will receive a placebo with standard reteplase treatment.
Main outcome variables
NIHSS Score Within 72 Hours of Admission
MRS score at three months post-discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240819062805N1
Registration date:2024-11-06, 1403/08/16
Registration timing:prospective
Last update:2024-11-06, 1403/08/16
Update count:0
Registration date
2024-11-06, 1403/08/16
Registrant information
Name
Mojdeh Ghabaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119
Email address
mojdeh.ghabaee@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-10, 1403/08/20
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of high-dose edaravone (Alsava) administered within the first 48 hours of hospitalization on short-term outcomes (NIHSS score) and long-term outcomes (MRS score) in patients with acute ischemic stroke eligible for Altylase(rTPA) therapy, admitted within 4.5 hours of symptom onset.
Public title
evaluating the clinical effects of high-dose edaravone (Alsava) in patients with acute cerebral stroke who are eligible for treatment with recombinant tissue plasminogen activator (rtPA).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged over 20 years
NIHSS score less than 4 accompanied by a disabling disorder.
Admission should occur within 0 to 4.5 hours following the onset of symptoms.
Administration of recombinant tissue plasminogen activator (rTPA)
Exclusion criteria:
History of Dementia
History of a brain mass
previous stroke
History of Brain Trauma
History of Brain Surgery
Debilitating neurological and/or systemic disorders that resulted in a pre-admission MRS greater than 0.
Renal and/or hepatic failure
Decompensated heart failure that precludes the administration of intravenous fluids in the volume necessary for the study.
History of Drug and Non-Drug Allergies
History of any potential allergic reactions to sulfite-containing medications.
pregnancy
History of Seizures
Patients eligible for mecanical thrombectomia
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
To achieve randomization, a block randomization method consisting of four blocks will be employed. A total of 30 blocks, each containing four participants, will be generated and utilized by the software. Patients will be assigned to either the intervention or control group in a random sequence as they enter the study, following the predetermined blocks and under the supervision of the supervisor. As a result, the clinical researcher will remain blinded to the blocking process and the allocation of patients to the respective groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This double-blind study involves sealed boxes containing either the main drug (Edaravon) or a placebo (distilled water), each paired with a syringe. Only the supervisor knows the code for each box, keeping the contents unknown to both patients and clinical assistants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committees of imam Romani hospital complex Tehran University of Medical Science
Street address
Imam Khomeini hospital, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.218
Health conditions studied
1
Description of health condition studied
acute ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
functional outcome is assessed based on the National Institutes of Health Stroke Scale (NIHSS) score and the Modified Rankin Scale (MRS) score.
Timepoint
NIHSS score recorded three days post-hospitalization; MRS score assessed three months following discharge.
Method of measurement
The standard forms for the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS)
Secondary outcomes
empty
Intervention groups
1
Description
In addition to receiving routine altilase treatment (biosimilar retplase from Arena Hayat Danesh Company), 2 vials of Alsava (20 mg/30 cc, biosimilar Edaravon from Zist Daro Danesh Company), diluted in 160 cc of normal saline and infused over 1 hr.Alsava will be administered every 12 hours for 48 hrs.
Category
Treatment - Drugs
2
Description
Control group: In addition to the standard treatment with altylase, a placebo consisting of 40 cc diluted in 160 cc of normal saline is administered via infusion every 12 hours for a duration of 48 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Stroke Center -Imam Khomeini Hospital, Tehran university of Medical Sciences
Full name of responsible person
Mojdeh Ghabaee
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Fax
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Saari
Street address
Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3685
Fax
+98 21 8895 3003
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
53
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
ZistDaru Danesh Company
Full name of responsible person
Ilka Houshmand
Street address
Unit 404, 4th Floor, Rose-mall Building, Hemmet Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1498711712
Phone
+98 21 4824 1000
Fax
+98 21 4231 8101
Email
info@zistdaru.com
Web page address
https://zistdaru.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ZistDaru Danesh Company
Proportion provided by this source
47
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh Ghabaee
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sabbatical to stroke
Street address
Imam Khomeini hospital, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6694 8899
Email
Mojdeh.ghabaee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh Ghabaee
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sabbatical to stroke
Street address
Imam Khomeini hospital, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6694 8899
Email
Mojdeh.ghabaee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh Ghabaee
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sabbatical to stroke
Street address
Imam Khomeini hospital, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6694 8899
Email
Mojdeh.ghabaee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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When the data will become available and for how long
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