Evaluation the effect of colchicine on the outcome and noreflow of blood in the coronary arteries in patients undergoing primary percutaneous coronary intervention in patients with acute myocardial infarction

Investigating the effect of colchicine on the outcome and lack of reflow of blood in the coronary arteries in patients undergoing primary percutaneous coronary intervention in acute myocardial infarction patients.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 350 patients in a randomized manner

Patients with acute heart attack referred to Seyed al-Shohadah center who will undergo initial percutaneous intervention will be randomly treated with colchicine, and then the phenomenon of no reflow of blood in the coronary arteries and other outcomes will be recorded and will be evaluated

Patients aged 18 to 80 who had ST elevation myocardial infarction for the first time and underwent percutaneous primary intervention will be included in the study. Exclusion criteria include: hemodynamic instability, liver failure, kidney failure , history of blood disease and chronic use of colchicine.

Patients will receive an equal amount of colchicine or placebo at the time closest to PCI. Patients in the case group will receive 2 mg oral colchicine as a loading dose, then 0.5 mg colchicine twice a day for 30 days. Loading dose must be given to patients before PCI and it is not possible to administer it after PCI.

Checking TIMI FLOW before and after stent implantation, checking the amount of TROPONIN at the beginning and 24 and 48 hours later, checking the amount of CRP at the beginning and 48 hours later, determining the occluded vessel that led to AMI, checking LVEF before Discharge, check for MACE (major adverse cardiac events which include target vessel revascularization, target lesion revascularization, new hospitalization due to heart failure, stroke, nonfatal myocardial infarction, and cardiac death) for one month

Changing the sample size Due to the reduction of the cold weather last year (and as a result the reduction of angina pectoris last year) and due to the failure of the cat lab of Seyed Al-Shohada Center and the lack of a suitable stent size for several months, a large number of acute myocardial infarction patients were treated with thrombolytics and removed from my study. After consulting with the supervisor and statistical consultant, while maintaining the power of the study and according to the statistical formula, the sample size was reduced to at least 120 samples (at least 60 samples in each group) by the statistician.

Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (100 patients), 25 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers.

The researcher gave the drug and the placebo, which had the same appearance, to the emergency doctor in the same numbered packages (only the researcher knows the type of drugs in the packages) and the emergency doctor block randomly prescribed the mentioned drugs to heart attack patients and the doctor interpreted The angiographer and the doctor who performs the echocardiography do not know the type of drug the patient is taking, and in the last step, before analyzing the data, the type of the patient's drug is extracted by the researcher from the list by the number of the drug envelope, and then the data is extracted is analyzed by the statistician.