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IRCT20220723055534N1 IRCT 2023-04-12 Qazvin University of Medical Sciences Colchicine in myocardial infarction The effect of colchicine on reperfusion arrhythmias in ST-elevation myocardial infarction (STEMI) patients treated with Primary Percutaneous Coronary Intervention (PPCI) 2022-08-27 anticipated 154 Complete https://irct.ir/trial/64974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into 2 groups. The division of people between two groups will be in a double-blind manner, and the type of randomization will be by Block randomization method, after the exit of people with exclusion criteria. The method of performing randomization is in such a way that at first, the number of samples will be given to the Random Allocation Software version 1.0.0. In the next step, it will be determined that each number will be placed in which study group, and the main drug or placebo will be placed in the drug package of that code. When patients admitted to the medical center, drug packages are prescribed for them in the order of number, Blinding description: In this study, the following people are blinded to the study groups: - Patients included in the study - Nurses who give colchicine or placebo to patients. - Cardiologist who performs PPCI for patients and report angiography results. - Nurses and researchers who evaluate the incidence of arrhythmia in patients. Considering that the packaging of medicines and numbering on the medicine packages will be done by other people and all the medicine packages are similar, none of the groups mentioned above have any knowledge of the type of medicine prescribed for the patient. . In the data analysis stage, the code of drug packages and their contents will be entered in the database file and the analysis will be done based on the type of drug. 3 Condition 1: ST-elevation myocardial infarction. Condition 2: Cardiac arrhythmia. Intervention 1: Intervention group: STEMI patients who are candidates for PPCI, before PCI, receive 2 grams of colchicine as STAT, and from the second day, 0.5 mg of colchicine will be prescribed every twelve hours for 5 days. Intervention 2: Control group: These patients are candidates for PPCI, but they will receive placebo instead of colchicine. Yes - There is a plan to make this available What will be shared: The entire data of this study will be shared based on the request of the journal in which the article of this study will be published after de-identifying the individuals. When: After publishing the results and printing the article To whom: All people who need the data of this study Conditions: --- Where to obtain: Seyed Amir Reza Mohajeri a.mohajeri@qums.ac.ir s.a.r.mohajery@gmail.com Majid Hajikarimi majidhajikarimi57@gmail.com How to obtain: After receiving the applicant's request, this request will be submitted to the research assistant of Qazvin University of Medical Sciences, and if approved by this assistant, the information will be sent. This process will take about 2 weeks to a month. Comments:
public Majid Hajikarimi
Buali Hospital, Buali ave.
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3333 2930 majidhajikarimi57@gmail.com Qazvin University of Medical Sciences scientific Majid Hajikarimi
Buali Hospital, Buali ave.
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3333 2930 majidhajikarimi57@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with STEMI that are candidates for PPCI no limit no limit Both Patients who previously used Colchicine or Prednisolone for any reason Contraindications of Colchicine, including sensitivity to Colchicine, kidney failure (GFR < 10), liver failure (AST - ALT above 5 times normal) and definite history of serious liver diseases (such as hepatitis, hemochromatosis, Wilson's disease, cirrhosis) Drugs that interact with risk X with colchicine I21 I49 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Other cardiac arrhythmias Treatment - Drugs Placebo Intervention group: STEMI patients who are candidates for PPCI, before PCI, receive 2 grams of colchicine as STAT, and from the second day, 0.5 mg of colchicine will be prescribed every twelve hours for 5 days. Control group: These patients are candidates for PPCI, but they will receive placebo instead of colchicine. The incidence of cardiac arrhythmia. Timepoint: The first day after the occurrence of STEMI. Method of measurement: Checking the rhythm recorded in the 24-hour monitor of the patient. Cardiac arrhythmia type in the first 24 hours after PPCI. Timepoint: The first day after the occurrence of STEMI. Method of measurement: Checking the rhythm recorded in the 24-hour monitor of the patient. Comparison of initial and final TIMI of involved vessels. Timepoint: At the beginning and end of coronary angiography. Method of measurement: Based on the standard specified in Branwald's cardiology book, the division is done. Qazvin University of Medical Sciences Approved 2022-07-02 Research Ethics Committees of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin Qazvin Qazvin Iran (Islamic Republic of)