IRCT20230801059005N1 IRCT 2023-08-21 Shiraz University of Medical Sciences Colchicine effects on Major Adverse Cardiac Events in patients who underwent PCI Evaluation the outcomes of major adverse cardiac events after six-month colchicine consumption in the patients with ST-elevation myocardial infarction that underwent primary percutaneous coronary intervention. 2023-09-23 anticipated 204 Complete https://irct.ir/trial/71847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Screening, randomization, and administration of colchicine or placebo to patients are performed on the first day of disease diagnosis. Each patient, for entry into the study, reads an informed consent form and declares their willingness or unwillingness to participate in the research. Patients are randomly divided into two equal groups. In the intervention group, in addition to standard treatment for myocardial infarction with ST-segment elevation, colchicine is administered orally (tablet) at a daily dose of 0.5 milligrams (half in the morning, half at night). In the control group, in addition to the mentioned standard treatment, placebo is administered, which is packaged, colored, and sized similarly to colchicine. After discharge, the patients' first follow-up is conducted one week later through a clinic visit. Subsequently, patients are visited monthly for six months in the clinic, and their drug tolerance, adherence to prescribed treatment, and major adverse cardiac events are monitored. To ensure greater confidence, all patients are assessed every two months by two cardiologists who are unaware of patient grouping, for major adverse cardiac events, Blinding description: To ensure fairness and reduce bias, we utilized a computer-based program with a block randomization protocol, and the block size factor was determined by the study investigators. Independent packaging personnel, not involved in the rest of the study, prepared the medication packages. All investigators, patients, and follow-up team members were kept unaware of the treatment assignments throughout the study, ensuring a non-biased controlled study. However, the blinding was broken in exceptional cases where knowledge of treatment allocation was necessary to manage seriously ill patients. 3 ST-elevation myocardial infarction. Intervention 1: Intervention group: In the intervention group, in addition to standard treatment for myocardial infarction with ST-segment elevation, colchicine is administered orally (tablet) at a daily dose of 0.5 milligrams (half in the morning, half at night). Intervention 2: Control group: In the control group, in addition to the mentioned standard treatment, placebo is administered, which is packaged, colored, and sized similarly to colchicine. Yes - There is a plan to make this available What will be shared: Only a part of data like primary outcome can be shared. When: The access period starts 1 year after the publication time of results To whom: This data will be available only to researchers working in academic and scientific institutions. Conditions: The data will be made available to researchers for further studies or more advanced analysis. Where to obtain: Researchers can send an email regarding the request for the data of our study to Dr. Hamed Bazrafshan. Email: Hamedbazrafshan@yahoo.com How to obtain: The researchers can request for this study's data through an e-mail one year after the publication data of this study in one of the pee-reviewed journals. Comments: