Investigating the anti-inflammatory effect of colchicine in patients undergoing coronary artery bypass graft (CABG) in Semnan kosar hospital in 1401: A randomized clinical trial

Studying the anti-inflammatory effect of colchicine in patients undergoing coronary artery bypass graft in Kosar Semnan hospital

A clinical trial with a control group, with parallel groups, double-blind, randomized into two identical groups, single-center, with a sample size of 90 people.

Kosar Semnan hospital; 45 patients receive daily colchicine (1 mg daily) plus atorvastatin 80 mg daily from 3 days before surgery to 4 days after surgery. 45 patients also receive only atorvastatin 80 mg daily from 3 days before surgery to 4 days after surgery. The participant, the principal investigator, and the health care personnel who will evaluate and collect the results will not know about the grouping of the patients and the type of drugs.

Inclusion criteria: The age range of people over 30 and under 80; informed consent; Need for CABG surgery. Exclusion criteria: Patients should have contraindications to colchicine or atorvastatin; Patients with a history of severe liver diseases; Patients who have creatinine clearance less than 50; Patients with a history of atrial fibrillation or atrial flutter or 2nd and 3rd-degree heart block.

Intervention group: 45 patients receive daily colchicine (1 mg daily) plus atorvastatin 80 mg daily from 3 days before surgery to 4 days after surgery. Control group: 45 patients received only atorvastatin 80 mg daily from 3 days before surgery to 4 days after surgery.

CRP serum level; Interleukin 6.

Given that in this study, matching is going to be done based on gender and age group, and we want the number of participants in the intervention and control groups to be balanced as much as possible, so the randomization Stratified permuted block randomization method is used in this study. The age range of patients is 30 to 80 years. Therefore, patients are divided into two groups, 30-55 years old (younger) and 56-80 years old (older), based on the cut-off point in the middle of this range (55 years). According to the above-mentioned gender and age grouping, eligible patients are classified into 4 stratums: Younger men, older men, younger women, older women Considering that the study is of parallel type and two groups (parallel), the allocation of eligible patients (according to the defined entry and exit criteria) to the intervention and comparison groups is done separately in each of the above-mentioned strata. The two intervention and comparison groups should be matched in terms of age group and gender. The sample size in each group is 45 people (90 people in total). We use blocks of four with numbers 1 to 6 as follows (in each block, a means the intervention group and b means the comparison group): 1-aabb 2-abba 3-abab 4-baba 5-baab 6-bbaa By choosing the numbers using the table of random numbers based on the numbers one to six, select the above blocks in order and from left to right, the eligible people of each stratum in the order of entering the study and after obtaining informed consent to one of the two groups a or We attribute b. This selection is made 22 times and the first 88 eligible people are assigned to the groups. For the last two people, we use a tap or a line to complete the sample list of 90 people and complete the balance.

Both groups receive atorvastatin. Therefore, this drug does not require blinding. Regarding colchicine, a placebo will be used. That is, colchicine is given to the intervention group, and a placebo (instead of colchicine and completely similar to it in terms of appearance) is given to the control group. The drugs (or placebos) are placed in coded packages and are available to the researcher in the clinic. The researcher gives each patient a package (containing medicine or placebo), and the package delivery is based on the code specified for each participant (from the first to the ninety). The patients and the researcher will not be aware of the content of the package. Only the collaborator of the project (who is responsible for concealment management and also has the randomization list) is aware of the list and codes, which at the end of the study and after the analysis (or in (in case of emergency) can reveal the code.