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Comparison of the effectiveness of ّ prescribing Fingolimod with Non-prescribing fingolimod in improving stroke related scales in Acute Ischemic Stroke(AIS) patients referring in 4.5 hours of symptoms onset

Protocol summary

Study aim
Comparison of the effectiveness of ّ prescribing Fingolimod with Non-prescribing fingolimod in improving stroke related scales in Acute Ischemic Stroke(AIS) patients referring in 4.5 hours of symptoms onset
Design
A double blind, randomized, parallel group phase 2-3 trial design of 50 patients, whom will be enrolled between may 2022 and July 2022, and will befollowed for 6 months.
Settings and conduct
Patients, who are suspected of acute ischemic stroke, referring to emergency ward of Tehran's Shariati hospital who have acute neurologic deficits with NIHSS more than 6 and no ICH in entrance brain CT and no exclusion criteria will be divided in two arms whom both get a standard stroke care receiving fingolimod in one and placebo in another by random thereby assessing in determined times. The pharmaceutical intermediary will give medicine and placebo as group A and B to the researcher(blinded); afterwards, the researcher will inform the prescribing physician(blinded) the A or B group on the basis of 2*2 blocked randomization; at last, patients will be assessed at entrance, 1month and 6 months later by assessing physician(blinded).
Participants/Inclusion and exclusion criteria
Patients with acute onset focal neurologic deficit with Age more then 18 years who referring to hospital in less than 4.5 hours: excluded by major heart retinal problems, age more than 80 or whom have ICH in entrance CT-scan
Intervention groups
In the first group , patients will get routine standard care including thrombolysis in conjunction with fingolimod , as a neuroprotective drug, for assessing whether there is an efficacy in determined time windows . simultaneously, control group will get the same care except fingolimod.
Main outcome variables
NIHSS and MRS scale in 0, 1, 6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220423054619N1
Registration date: 2022-05-29, 1401/03/08
Registration timing: registered_while_recruiting

Last update: 2022-05-29, 1401/03/08
Update count: 0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
Hamed Shahriyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7671 0756
Email address
hamedshahriyari69@icloud.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ّ prescribing Fingolimod with Non-prescribing fingolimod in improving stroke related scales in Acute Ischemic Stroke(AIS) patients referring in 4.5 hours of symptoms onset
Public title
Effect of Fingolimod in acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute onset focal neurologic deficit Age more then 18 years referring to hospital in less than 4.5 hours
Exclusion criteria:
Age more than 80 History of moderate or severe cardiovascular condition History of prior probable retinal problems Active viral or bacterial infection Suspicion of other neurologic conditions than CVA No existing hyperdense lesion in entry CT scan consisting with hemorrhagic lesion
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, Randomization is performing in 2*2 blocking in individualized manner using “Random Allocation” software. Afterwards, placebo and medication consign to blinded researcher by an intermediary as group A and B. At last, Researcher will allocate the medication or placebo to the first line physicians of trial to prescribe them for enrolled patients, whom are blinded, based on the determined randomized blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Firstly, the researcher receive two groups of placebo and real medication in similar form, then the assessor physician will evaluate the patients without any information of the patient's assigned group; finally, the analysist do the analysis just based on the two groups without prior knowledge
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran university of medical sciences, Poursina street
City
Tehran
Province
Tehran
Postal code
1417613151]
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.599

Health conditions studied

1

Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
I63.00
ICD-10 code description
Cerebral infarction due to thrombosis of unspecified precerebral artery

Primary outcomes

1

Description
National Institutes of Health Stroke Scale
Timepoint
At entrance , first month and 6th month after intervention
Method of measurement
Neurologic examination of neurologist

2

Description
The Modified Rankin Scale (mRS) for neurologic disability
Timepoint
Neurologic examination of neurologist
Method of measurement
The Modified Rankin Scale (mRS) for neurologic disability

Secondary outcomes

1

Description
Hemorrhagic changes of stroke territory
Timepoint
3th and 7th day after stroke
Method of measurement
CT scan by neurologist

Intervention groups

1

Description
Intervention group: prescribing fingolimod 0.5 miligrams at entrance and after 24 hours
Category
Treatment - Drugs

2

Description
Control group: prescribing placebo at entrance and after 24 hours
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Hamed Shahriyari
Street address
North Karegar street
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8490 1000
Email
hamedshahriyari69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran university of medical sciences, Poursina street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8889 6696
Email
tumspr@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
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
Tehran University of Medical Sciences
Full name of responsible person
Hamed Shahriyari
Position
Non consultant specialized physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No18, West 186th street, Bagheri highway, Tehran pars
City
Tehran
Province
Tehran
Postal code
1685883911
Phone
+98 21 7671 0756
Email
hamedshahriyari69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Shahriyari
Position
Non consultant specialized physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No18, West 186th street, Bagheri highway, Tehran pars
City
تهران
Province
Tehran
Postal code
1685883911
Phone
+98 21 7671 0756
Email
hamedshahtiyari69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Shahriyari
Position
Non consultant specialized physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No18, West 186th street, Bagheri highway, Tehran pars
City
Tehran
Province
Tehran
Postal code
1685883911
Phone
+98 21 7671 0756
Email
HamedShahriyari69@gmail.com

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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
demographic data will be reported as well as the results
When the data will become available and for how long
data will be available in 6 to 9 months after the study publish
To whom data/document is available
the health care professionals interested in the study subject will be allowed
Under which criteria data/document could be used
The data will be given providing authentication of the researcher and all kinds of analysis will be allowed
From where data/document is obtainable
The study attendant Hamed Shahriyari hamedshahriyari69@gmail.com 0098 912 7962384
What processes are involved for a request to access data/document
After introducing and official application by an email, the study characteristics will be requested and if it is amenable, the data will be shared by excel or similar sheets.
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