Evaluation of the efficacy and safety of colchicine in the prevention for post-CABG atrial fibrillation: a randomized double-blind placebo- controlled trial

Evaluation of the efficacy and safety of colchicine in the prevention for post-CABG atrial fibrillation

A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 172 patients. The rand function of Excel software was used for randomization.

This study will be held in Fatemeh Zahra Sari Heart Center, affiliated to Mazandaran University of Medical Sciences. a data collection form designed by the research team will be used to collect information. In the first part, demographic Characteristics of Patients and in the second part, related information. The patient will be recorded for Hospitalization and Treatment such as Atrial Fibrillation, number of Days hospitalized in the ICU, number of Days hospitalized and the incidence of complications due to Colchicine consumption such as gastrointestinal intolerance, etc. Patients and clinical invistigator and outcome analysts are blinded.

Inclusion criteria: Patients between 18_80 years old with Coronary Artery Disease that are Candidates for Coronary Artery Bypass Grafting surgery

In this Study, 172 Patients with inclusion criteria will be randomly divided into two Groups of Patients receiving Colchicine and the Control Group (placebo). Patients in the first Group, will be given 1 mg of Colchicine every 12 hours for 24 hours before surgery, then 0.5 mg daily if they weigh less than 70 kg, or 1mg daily if >70kg for 14 days. Patients in the second group will also be given a placebo, similar to the conditions in the first group.

Duration of ICU stays, Duration of hospitalization, POAF or Atrial fibrillation, inflammatory factors(CRP,IL6)

The grouping of patients and the type of intervention received is at the disposal of the first executive of the plan. The patient, assistant clinical pharmacist and statistical analyst will not know about the grouping of patients. Clichesin and placebo drugs will be placed in an envelope based on predetermined codes and will be provided to the participants based on randomization. Patients will be randomly assigned using the online system https://www.sealedenvelope.com/simple-randomiser/v1/lists in 43 blocks of 4 as follows: ABBA, ABBA, BAAB, BBAA, ABBA, BAAB, AABB, ABAB, AABB, ABBA, BABA, AABB, BBAA, AABB, ABAB, BAAB, BABA, BAAB, ABBA, BAAB, BABA, ABAB, ABBA, ABAB, ABAB, AABB, BABA, BBAA, BAAB, BBAA, BBAA, BBAA, AABB, ABBA, BAAB, AABB, ABAB, BBAA, BAAB, BBAA, BBAA, ABBA, ABBA

This study will be double blind. In this way, the patient, the assistant clinical pharmacist and the statistical analyst will not know about the drug used (colchicine or placebo). The grouping of patients and the type of intervention received are at the disposal of the first executive of the project. Colchicine and placebo drugs will be placed in an envelope according to the predetermined codes and will be given to the participants based on randomization. Colchicine drug is prepared as a standard treatment by the operator. The preparation of colchcine and its brand is checked and approved by the project manager. An arrangement should be made so that all patients use clichicine from the same pharmaceutical company. Medicines and placebos will be procured from the same pharmaceutical company. The colchicine and placebo medicines will be placed in an envelope according to the predetermined codes and will be provided to the participants based on randomization.

All data can be shared

After publishement

Every one

Without specific roules

In addition to correspondence with the website of the magazine that publishes the project article, applicants can send their application to the executive or project manager if needed.

Searching the databases of article publishers online After sending the application to the project manager via email or fax number or visiting in person at the mentioned address and confirmed by the project manager, the information will be available to the applicants. Hamideh Abbaspour Kasgari dr.abbaspour1@yahoo.com