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IRCT20231001059578N1 IRCT 2023-10-21 Ghoum University of Medical Sciences Evaluation of the colchicine on the myocardial infarction Evaluation of the low dose colchicine on the clinical outcome of patient with ST elevation myocardial infarction 2023-10-03 anticipated 180 Complete https://irct.ir/trial/72937 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A lottery method will be used to assign patients to two intervention and control groups. In the first stage, the groups are written in the form of group A, B. Then, a lottery is drawn between the two groups to determine which is the intervention group and which is the control group. In the second step, the numbers of two cards written on one A and the other B and completely closed and not visible are thrown into a container. In the third stage, after obtaining consent from the patients and agreeing to participate in the study, they are asked to choose one of the two cards in the container in order to determine the treatment group. Then he takes a card from inside the container and hands it to the nurse. The nurse writes down the treatment group and the patient's medicine is prescribed according to the group it belongs to. This work will continue until 90 people in both groups are completed, Blinding description: In order to observe blinding, the researcher and the patient will be unaware of the type of treatment group of the patients. The intervention in this study is colchicine with a dose of 0.5 mg, which is prescribed for the patients of the intervention group, and the placebo drug, which is similar to colchicine in terms of color, size and packaging, will be prescribed for the patients of the control group. Labeling, blinding, packaging of drugs and delivery of drugs to patients will be done by a person not familiar with the study (ward head). 3 myocardial infarction. Intervention 1: An oral loading dose of 2 mg equivalent to 2 colchicine (from Mofid Pharma Pharmaceutical Company) tablets will be given to the patients, followed by 0.5 mg once a day orally for 30 days. Intervention 2: Control group: Placebo (from Mofid Pharma Pharmaceutical Company) medicine, which is similar to colchicine in terms of color, size and packaging, will be prescribed for control group patients. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: from 2024 To whom: all people Conditions: If the data and documents of this study are needed to conduct larger studies, the administrators of this study will provide all the data to the administrators of other studies. Where to obtain: dr khosrobeigi, ali.khosrobeigi@gmail.com How to obtain: ali.khosrobeigi@gmail.com Comments:
public Ali khosrobeigi
shahid beheshti hospital Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3612 2000 ali.khosrobeigi@gmail.com Ghoum University of Medical Sciences scientific Ali khosrobeigi
shahid beheshti hospital Qom
qom Iran (Islamic Republic of) 3713649373 +98 25 3612 2000 ali.khosrobeigi@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) 18 to 80 years old patient Occurrence of STE in the patient's ECG 18 years 80 years Both Unstable vital signs of patients Known drug sensitivity to colchicine Severe liver and kidney disease Chronic treatment with colchicine I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo An oral loading dose of 2 mg equivalent to 2 colchicine (from Mofid Pharma Pharmaceutical Company) tablets will be given to the patients, followed by 0.5 mg once a day orally for 30 days. Control group: Placebo (from Mofid Pharma Pharmaceutical Company) medicine, which is similar to colchicine in terms of color, size and packaging, will be prescribed for control group patients. The functional class of the patient until the occurrence of chest pain. Timepoint: At the beginning of the study, the first day, when the patients were discharged and after 40 days from intervention. Method of measurement: check list. Ghoum University of Medical Sciences Approved 2023-01-30 Ethics committee of Qom University of Medical Sciences Shahid Lavasani St. (Saheli) - Qom University of Medical Sciences - Qom Qom Ghoum Iran (Islamic Republic of)