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IRCT20120111008698N23 IRCT 2018-07-15 Deputy of Research and Technology of Tehran University of Medical Sciences Evaluation of anti-inflammatory effects of colchicine on the blood flow of heart's vessels and heart's muscle in patients who undergo angioplasty in the acute phase of heart attack Anti-inflammatory Effects of Colchicine on Thrombolysis in myocardial infarction (TIMI) flow grade, Myocardial Perfusion Grade (MPG) and no-reflow rate in patients undergoing Primary Percutaneous coronary intervention (PCI) in acute MI phase 2018-02-26 anticipated 320 Complete https://irct.ir/trial/9197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, Permuted Block randomization method was used individually. The randomized list of numbers 1 to 320 is randomly divided into two groups A or B, and the admitted patients are listed in group A or B, respectively, Blinding description: In this study, both participants and researchers, all physicians involved in the treatment of patients are unaware of the allocation of study groups, and those who prepare a draft article are also kept blind to the allocation of blind study groups Patients in group A or B and receiving a drug or placebo by the patient are unaware. N/A Acute myocardial infarction. Intervention 1: Intervention group: Oral colchicine (Modava, Tehran) 1mg followed by 0.5 mg after PCI. Intervention 2: Control group: Placebo of colchicine was administered at the dose of 1 mg followed by 0.5 mg after one hour of PCI. Yes - There is a plan to make this available What will be shared: Data such as primary and secondary outcome information When: Start the access period 6 months after printing the results To whom: For researchers working in academic and scientific institutions Conditions: Conditions for using the data or documentation will be determined depending on the type of use, with the coordinator of the project Where to obtain: E-mail: a-talasaz@tums.ac.ir How to obtain: E-mail: a-talasaz@tums.ac.ir Comments:
public Dr.Seyed Hossein Hosseini
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 88029731 +98 21 8802 9261 hossein5859@yahoo.com Tehran University of Medical Sciences scientific Dr Azita Hajhossein Talasaz
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 88029731 +98 21 8802 9242 atalasaz@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for the Primary PCI Pain or chest discomfort greater than or equal to 20 minutes, less than or equal to 12 hours, and ST elevation ≥ 1 mm in the adjacent limb leads and precordial leads except for V2, V3, or ST elevation ≥ 2 mm in V2, V3 in men or ST height ≥ 1.5 mm in V2, V3 in women. Obtain informed consent from all patients before enrollment no limit no limit Both Patients who are only undergoing angiography for diagnostic purposes and do not undergo PCI Patients who have been treated with Colchicine due to chronic illness Colchicine intolerance history Glumerolar filtration Rate less than 30 ml/min and Dialysis patients Malignancy and infection Oral steroids or NSAIDs ( Except for aspirin) within 72 hours prior to PCI Use of CYP 3A4 / P-glycoprotein inhibitor drugs (Ritonavir / Ketoconazole / Clarithromycin / Cyclosporine / Diltiazem / Vrapaemia) Patients who suffered cardiac arrest, cardiogenic shock (systolic pressure less than 90), VF, or under CPR in emergency setting Start angina more than 12 hours I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention group: Oral colchicine (Modava, Tehran) 1mg followed by 0.5 mg after PCI Control group: Placebo of colchicine was administered at the dose of 1 mg followed by 0.5 mg after one hour of PCI Coronary blood flow and myocardial perfusion. Timepoint: during angiography. Method of measurement: TIMI flow criteria and observations during the angiography. Hs-CRP. Timepoint: baseline and 48 hours after PCI. Method of measurement: blood sample. TNT. Timepoint: baseline and 6 hours and 24 hours and 48 hours after PCI. Method of measurement: blood sample. P-selectin. Timepoint: baseline and 24 hours after PCI. Method of measurement: blood sample. 30 day MACE. Timepoint: one month after PCI. Method of measurement: follow-up visit or phone call. Deputy of Research and Technology of Tehran University of Medical Sciences Approved 2018-02-25 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)