]>
IRCT20220423054619N1 IRCT 2022-05-29 Tehran University of Medical Sciences Effect of Fingolimod in acute ischemic stroke 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 2022-05-22 anticipated 50 Complete https://irct.ir/trial/63185 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Acute Ischemic Stroke. Intervention 1: Intervention group: prescribing fingolimod 0.5 miligrams at entrance and after 24 hours. Intervention 2: Control group: prescribing placebo at entrance and after 24 hours. Yes - There is a plan to make this available What will be shared: demographic data will be reported as well as the results When: data will be available in 6 to 9 months after the study publish To whom: the health care professionals interested in the study subject will be allowed Conditions: The data will be given providing authentication of the researcher and all kinds of analysis will be allowed Where to obtain: The study attendant Hamed Shahriyari hamedshahriyari69@gmail.com 0098 912 7962384 How to obtain: 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. Comments:
public Hamed Shahriyari
No18, West 186th street, Bagheri highway, Tehran pars
Tehran Iran (Islamic Republic of) 1685883911 +98 21 7671 0756 hamedshahriyari69@gmail.com Tehran University of Medical Sciences scientific Hamed Shahriyari
No18, West 186th street, Bagheri highway, Tehran pars
تهران Iran (Islamic Republic of) 1685883911 +98 21 7671 0756 hamedshahtiyari69@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Acute onset focal neurologic deficit Age more then 18 years referring to hospital in less than 4.5 hours 18 years 80 years Both 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 I63.00 Cerebral infarction due to thrombosis of unspecified precerebral artery Treatment - Drugs Placebo Intervention group: prescribing fingolimod 0.5 miligrams at entrance and after 24 hours Control group: prescribing placebo at entrance and after 24 hours National Institutes of Health Stroke Scale. Timepoint: At entrance , first month and 6th month after intervention. Method of measurement: Neurologic examination of neurologist. The Modified Rankin Scale (mRS) for neurologic disability. Timepoint: Neurologic examination of neurologist. Method of measurement: The Modified Rankin Scale (mRS) for neurologic disability. Hemorrhagic changes of stroke territory. Timepoint: 3th and 7th day after stroke. Method of measurement: CT scan by neurologist. Tehran University of Medical Sciences Approved 2019-11-23 Ethics committee of Tehran University of Medical Sciences Tehran university of medical sciences, Poursina street Tehran Tehran Iran (Islamic Republic of)