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IRCT20210423051047N2 IRCT 2021-09-10 Iran University of Medical Sciences Colchicine in patients with myocardial infarction Anti-inflammatory effect of cholchicine in acute coronary syndrome 2021-06-27 anticipated 80 Complete https://irct.ir/trial/55816 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 patients, using random allocation software, were randomly divided into two groups. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers. The tool used is random allocation software version 2.0 in which by selecting the number of groups and the sample size, a random sequence sheet is provided for the control and intervention group, Blinding description: This study will be Triple-blind. The treating physician and patients will be blinded to the type of intervention and the data analyzer who must analyze the data ]will be blinded to the type of intervention. 2 Acute myocardial infarction. Intervention 1: Intervention group: Patients receive 1 mg colchicine tablet made by Modava Pharmaceutical Company as 1 mg at first and 1 mg one hour after Primary PCI. Intervention 2: Control group: Patients receive colchicine placebo made in the laboratory of Islamic Azad School of Pharmacy at the beginning and one hour after Primary PCI. Yes - There is a plan to make this available What will be shared: The study report will be available as an article When: September 2021 To whom: Researchers working in academic and scientific institutions Conditions: Upon written request and the protection of the rights of the study authorities, the approved items above will be available. Where to obtain: Dr. Somayyeh Nasiripour, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences Email: Nasiripours@yahoo.com How to obtain: Upon a written request, the study authorities will review it and then provide the documentation at its discretion. Comments:
public Maryam Farasatinasab
Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 0098218214000 maryfarasati@gmail.com Iran University of Medical Sciences scientific Somayyeh Nasiripour
Niayesh St, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 8811 nasiripours@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) A patient over 20 years of age with ST Elevated MI who is a candidate for Primary PCI and presented within less than 12 hours of the onset of pain 20 years no limit Both Cardiogenic shock or hemodynamic instability Known hypersensitivity to colchicine Patients with a history of chronic kidney and liver disease Thrombocytopenia or leukopenia Pregnant or lactating women Patients receiving CYP3A4 inhibitors Patients already taking colchicine Patients who have evidence of active or inflammatory infection Patients with a history of AF or MI Patients with a history of CABG MI patients in the field of stent thrombosis I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs Intervention group: Patients receive 1 mg colchicine tablet made by Modava Pharmaceutical Company as 1 mg at first and 1 mg one hour after Primary PCI Control group: Patients receive colchicine placebo made in the laboratory of Islamic Azad School of Pharmacy at the beginning and one hour after Primary PCI. Assessment of interleukin 1B levels. Timepoint: 24 hours after intervention. Method of measurement: Elisa Kit. Evaluation of recurrent myocardial infarction. Timepoint: On a daily basis from the start of the intervention. Method of measurement: Follow-up of symptoms of myocardial infarction. Iran University of Medical Sciences Approved 2021-02-22 Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)