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IRCT20181009041286N2 IRCT 2021-10-03 Kashan University of Medical Sciences "effect of atorvastatin and rosuvastatin in acute ischemic stroke patients" Investigating the effect of atorvastatin and rosuvastatin on serum immune factors in acute ischemic stroke patients 2021-10-15 anticipated 40 Complete https://irct.ir/trial/52556 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Randomization is done by permuted block randomization method, so that first all size of 4 blocks that contain two letters A & B are prepared (6 blocks) and we assign a number from 1 to 6 to each of them. Then, using a table of random numbers, numbers from one to six are selected (80 numbers) and based on the selected random numbers, the corresponding block will be written. Doing so will result in a sequence of 80 letters A and B. Each sample will have a number from 1 to 80 if they enter the study, which will receive codes A and B based on the letter list based on each person's number. This will both randomize and make both groups almost identical, Blinding description: After obtaining consent based on random numbers, patients are divided into atrostatin and resvastatin groups and patients are not studied by the type of treatment received. The examining physician is not aware of the type of medication prescribed during the treatment period. And the patient's blood samples are sent to the laboratory without specifications and with a number. 2-3 Acute ischemic stroke. Intervention 1: Intervention group: Rusovastatin treatment group in which 40 mg of rusovastatin is given on the first day and then 20 mg of rusoavastatin every 12 hours for 5 days. The chemical composition of this drug is C22H28FN3O6S. Intervention 2: Intervention group: Atorvastatin treatment group in which 80 mg of atorvastatin on the first day and then 40 mg of atorvastatin every 12 hours for 5 days is prescribed. The chemical composition of this drug is C33H35FN2O5. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mohamad Sadegh Ghafarpour
Shahid Beheshti hospital, Ghotb Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 Dr.ms.ghafarpour@gmail.com Kashan University of Medical Sciences scientific Reza Daneshvar kakhki
Neurology ward, Beheshtei general hospital, Kashan, Isfahan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 daneshvar-r@mail.kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with acute brain ischemic stroke Referral in the first 24 hours after the onset of symptoms No recent history of statin use 18 years no limit Both Past history of autoimmune disease or rheumatology diseases Recent drug history of antineoplastic or anti-inflammatory Past history of statin's hypersensivity I63 Cerebral infarction Treatment - Drugs Treatment - Drugs Intervention group: Rusovastatin treatment group in which 40 mg of rusovastatin is given on the first day and then 20 mg of rusoavastatin every 12 hours for 5 days. The chemical composition of this drug is C22H28FN3O6S. Intervention group: Atorvastatin treatment group in which 80 mg of atorvastatin on the first day and then 40 mg of atorvastatin every 12 hours for 5 days is prescribed. The chemical composition of this drug is C33H35FN2O5. TNF alpha. Timepoint: before intervention and the fifth day after intervention. Method of measurement: TNF alpha willbe assay by ELISA. ESR 1 hour. Timepoint: before intervention and the fifth day after intervention. Method of measurement: Wintrobe method. C-reactive protein (CRP). Timepoint: before intervention and the fifth day after intervention. Method of measurement: Immunoturbidimetry. NIHSS: The National Institutes of Health Stroke Scale. Timepoint: before intervention and the fifth day after intervention. Method of measurement: The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment. The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke. Timepoint: before intervention and the fifth day after intervention. Method of measurement: a questionnaire used by healthcare providers. Kashan University of Medical Sciences Approved 2021-08-14 Ethics committee of Kashan University of Medical Sciences Beheshtei General Hospital, Pezeshk Ave, Ghotbe Ravandei Blvd Kashan Isfehan Iran (Islamic Republic of)