IRCT | Evaluating the Efficacy of Eicosapentaenoic Acid compared to placebo on Modified Rankin Scale and Inflammatory Biomarkers in Patients with Ischemic Stroke: A Randomized Controlled Trial.

Protocol summary

Study aim: Evaluating the efficacy of eicosapentaenoic acid on Modified Rankin Scale and inflammatory biomarkers in patients with ischemic stroke in a randomized controlled trial.
Design: A randomized, triple-blinded, controlled trial with parallel groups including 90 patients.
Settings and conduct: This study will be a randomized blinded, controlled trial, which will be conducted on ischemic stroke patients, hospitalized in the neurology department of Imam Hossein hospital. The drug and placebo are completely similar in appearance and will be packed in same jars, so all research's team will be blinded to the allocations. Block randomization will be utilized.
Participants/Inclusion and exclusion criteria: Inclusion criteria: patients more than 18 year old; with ischemic stroke hospitalized in the neurology department. Exclusion criteria: Patients treated with Alteplase, History of allergy and intolerance to fish liver oil and its derivatives, PLT< 50,000, Active bleeding or any history of active systemic bleeding disorder, Pregnancy & Lactation, Severe stroke (NIHSS score >20)
Intervention groups: The intervention group: they receive eicosapentaenoic acid with a daily dose of 2 grams. The control group: they receive placebo that is completely similar to the drug sample in terms of appearance, packaging and additives.
Main outcome variables: Modified Rankin Scale (mRS) in patients

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20170608034390N15

Registration date: 2024-07-31, 1403/05/10

Registration timing: prospective

Last update: 2024-07-31, 1403/05/10

Update count: 0
Registration date: 2024-07-31, 1403/05/10

Registrant information: Name

Hadi Esmaily

Name of organization / entity

SBMU

Country

Iran (Islamic Republic of)

Phone

+98 21 8887 3704

Email address

esmaily_hadi@sbmu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-08-22, 1403/06/01
Expected recruitment end date: 2025-01-20, 1403/11/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluating the Efficacy of Eicosapentaenoic Acid compared to placebo on Modified Rankin Scale and Inflammatory Biomarkers in Patients with Ischemic Stroke: A Randomized Controlled Trial.

Public title: Evaluating the efficacy of eicosapentanoic acid on modified Rankin scale and inflammatory biomarkers in patients with ischemic stroke.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients older than 18 years Ischemic stroke Hospitalized in neurology ward

Exclusion criteria:

Patients that are under treatment with Alteplase Patients with the history of allergy to fish liver oil and its derivatives. Patients with platelet level Count < 50,000. Patients with active bleeding. Patients with active systemic bleeding disorders. Pregnancy Lactation Patients with severe stroke (NIHSS score >20).
Age: From 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 90

Randomization (investigator's opinion)

Randomized

Randomization description

We will randomly divide the participants into two groups with the same size of 45 participants (90 patients in total), to ensure the equal distribution of patients in the two groups, the block randomization method will be used, and 9 blocks of 10 people in total will be created. Sealed Envelope online software (www.sealedenvelope.com) will be used to create random codes. Patients who meet the inclusion criteria receive the code in order and based on the grouping of random blocks, for example, the distribution and coding in the first block is as follows, the first patient Group A, the unique code is ZX6, the second patient Group A, the unique code is GA6, Group B third patient, FR9 code, Group B fourth patient, PP3 code, Group A fifth patient, FR9 code, Group B sixth patient, AE8 code. The number of patients in groups A and B in each block is equal.

Blinding (investigator's opinion)

Triple blinded

Blinding description

A placebo will be used for blinding, which is a 1000 mg softgels, containing corn oil, with the same size and color as the drug softgels, and it is produced in the Yas Kavir Meybod factory under GMP conditions. After preparing the drug and placebo, they will be packed in the same box by a clinical laboratory expert who is outside the research and will be provided with random codes based on the Excel file extracted from the Sealed Envelope software. The package will be transported to the clinic and the codes will closed till the statistical analysis is performed.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Pharmacy Faculty, Shahid Beheshti University of Medical Sciences

Street address

No.2660, Pharmacy Faculty, Shahid Beheshti University of Medical Sciences, Valiasr street

City

Tehran

Province

Tehran

Postal code

1467664961
Approval date: 2024-06-01, 1403/03/12
Ethics committee reference number: IR.SBMU.PHARMACY.REC.1403.105

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: Modified Rankin Scale (mRS) in patients
Timepoint: At the time of hospitalization, before discharge, and 3th months
Method of measurement: Clinical Scale

Secondary outcomes

1

Description: National Institute of Health Stroke Scale in patients
Timepoint: At the time of hospitalization, before discharge, and at third month
Method of measurement: Clinical Scale

Intervention groups

1

Description: Intervention group: Patients take an oral softgel containing 1000 mg of eicosapentaenoic acid in two divided doses, morning and evening, on a full stomach for 3 months.
Category: Treatment - Drugs

2

Description: Control group: The placebo will be produced in the same shape as the intervention product, containing corn oil, produced by the Yas Kavir Meybod factory under GMP conditions, and in the placebo group, patients will receive two placebo softgels daily in two divided doses, morning and evening, with a full stomach for 3 months.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Neurology department; Imam Hossein Hospital

Full name of responsible person

Mitra Mahmoudi Meymand

Street address

Shahid Madani street

City

Tehran

Province

Tehran

Postal code

1617763141

Phone

+98 21 7343 3000

Email

info@ehmc.ir

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Afshin Zarghi

Street address

Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences and Health Services, Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway

City

Tehran

Province

Tehran

Postal code

1985717443

Phone

+98 21 2243 9781

Email

zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti 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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Hadi Esmaily

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

School of Pharmacy, Shahid Beheshti University of Medical Sciences, Vali Ars street

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8887 3704

Fax

+98 21 8887 3704

Email

Esmaily_hadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Hadi Esmaily

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

School of Pharmacy, Shahid Beheshti University of Medical Sciences, Vali Ars street

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8887 3704

Fax

+98 21 8887 3704

Email

Esmaily_hadi@sbmu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Hadi Esmaily

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

School of Pharmacy, Shahid Beheshti University of Medical Sciences, Vali Ars street

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8887 3704

Fax

+98 21 8887 3704

Email

Esmaily_hadi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Potentially the whole data will be published after participants become unidentified
When the data will become available and for how long: The data will be available 6 months after data publication
To whom data/document is available: Industrial and Academic Researchers
Under which criteria data/document could be used: To carry out further research
From where data/document is obtainable: Dr. Hadi Esmaily, School of Pharmacy, Shahid Beheshti University of Medical Sciences.
What processes are involved for a request to access data/document: It can be provided by sending a request by email. Email to the person in charge of the study: Esmaily_hadi@sbmu.ac.ir
Comments

Evaluating the Efficacy of Eicosapentaenoic Acid compared to placebo on Modified Rankin Scale and Inflammatory Biomarkers in Patients with Ischemic Stroke: A Randomized Controlled Trial.