Investigating the impact of edaravone on CT scan, NIHSS and GSC duration in patients with ischemic stroke
Design
The current study is a Phase 3 randomized controlled clinical trial, wherein patients will be allocated to either the intervention group (receives edaravone) or the control group (receives placebo) based on predetermined inclusion and exclusion criteria, using random allocation via the envelope method. The sample size for each group will consist of 30 participants, totaling 60 individuals in the study.
Settings and conduct
This study will conducted on patients diagnosed with ischemic stroke, those admitted to Shahid Jalil Yasouj Hospital. Patients will receive detailed information regarding the study’s objectives and intervention, while remaining blinded to their assignment in either the intervention or control group. Caregivers and data analysts will also be blinded to group allocation. The study aims to assess the impact of the Daraven drug on NIHSS, and GSC, among patients with ischemic stroke.
Participants/Inclusion and exclusion criteria
People with ischemic stroke based on clinical symptoms and CT scan and NIHSS score greater than 16 will be included in this study, and participants who do not want to participate in the study or have hemorrhagic stroke or any cognitive and neurological deficits will be excluded from the study.
Intervention groups
The patients will be randomly divided into intervention and control groups, and the intervention group will receive 30 mg of the drug dissolved in 100 mg of normal saline for 60 minutes, twice a day for 10 days, and the control group will receive normal saline infusion as They will receive a placebo.
Main outcome variables
Consciousness of the patient; rate of clinical improvement; radiological improvement rate; severity of ischemia; Duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240224061102N1
Registration date:2024-05-11, 1403/02/22
Registration timing:prospective
Last update:2024-05-11, 1403/02/22
Update count:0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
sima shamsipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 9380
Email address
simashamsipour.5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of edaravone on the patients with ischemic stroke
Public title
Effectivnes of edaravone on ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants with ischemic stroke based on clinical symptoms and CT scan
Participants with ischemic stroke and NIHSS score of 16
Exclusion criteria:
Unwillingness to participate
Significant cognitive and neurological impairments
Presence of hemorrhagic stroke
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study utilized a sealed envelope method for randomization. This method involved preparing envelopes containing numbers 1-60, with eligible patients selecting an envelope at random to determine their treatment allocation. Patients who chose envelopes with odd numbers were assigned to the intervention group, while those with even numbers were assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study's objectives and intervention type will be thoroughly explained to all patients, while their assigned group will remain undisclosed to eliminate the placebo effect. Additionally, the project's researchers, including the individual examining and analyzing the data, will also be kept unaware of the participants' allocation to the control or intervention group to prevent any bias in care or data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasouj University of Medical Sciences
Street address
Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.YUMS.REC.1402.157
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Ischemic Severity
Timepoint
First and 10 days after intervention
Method of measurement
CT scan
2
Description
Radiological improvement rate
Timepoint
First and 10 days after intervention
Method of measurement
CT scan
3
Description
Rate of clinical improvement
Timepoint
First and 10 days after intervention
Method of measurement
NIHSS Scoring
4
Description
The level of consciousness of the patient
Timepoint
First and 10 days after intervention
Method of measurement
GCS scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: edaravone drug, 30 mg of the drug dissolved in 100 mg of normal saline for 60 minutes, will receive twice a day by injection for 10 days.
Category
Treatment - Drugs
2
Description
Control group: will receive normal saline infusion as a placebo for 60 minutes, twice a day by injection for 10 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasouj University of Medical Sciences
Full name of responsible person
Saeid Razmeh
Street address
Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Phone
+98 74 3226 9380
Email
srazmeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Phone
+98 74 3334 6079
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeid Razmeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Phone
+98 74 3226 9380
Email
srazmeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeid Razmeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Phone
+98 74 3226 9380
Email
srazmeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeid Razmeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Blvd,Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796847
Phone
+98 74 3226 9380
Email
srazmeh@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be 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