Post-operative atrial fibrillation after coronary artery bypass grafting (CABG)
Adults aged 20 years or older scheduled to undergo elective coronary artery bypass grafting (CABG), including either off-pump CABG or on-pump CABG.
Ability to receive oral study medication before and after surgery.
Provision of written informed consent before randomization.
History of atrial fibrillation or atrial flutter before surgery.
Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) or chronic dialysis.
Severe hepatic dysfunction.
Known hypersensitivity or previous severe adverse reaction to colchicine.
Parallel
Colchicine 0.5 MG oral tablet twice daily
DrugColchicine 0.5 mg administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7. Temporary interruption or discontinuation is permitted for clinically significant adverse events according to the study safety protocol.
Placebo Oral Tablet
DrugMatching placebo tablet administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7 under double-blind conditions.
Incidence of new-onset atrial fibrillation within 14 days after CABG surgery
New-onset atrial fibrillation (AF) or atrial flutter (AFL) lasting ≥30 seconds, documented by 12-lead ECG, continuous telemetry monitoring, or 24-hour Holter recording, occurring within 14 days after coronary artery bypass grafting (CABG). Events are adjudicated by blinded cardiologists according to prespecified criteria.
Total duration of post-operative atrial fibrillation (POAF)
Cumulative duration (in hours) of all atrial fibrillation or atrial flutter episodes documented by telemetry or ECG monitoring within 14 days after surgery.
Proportion of patients requiring cardioversion for POAF
Percentage of patients who undergo pharmacologic or electrical cardioversion for atrial fibrillation/flutter occurring within 14 days after surgery.
Total dose of intravenous amiodarone used for POAF treatment
Total cumulative intravenous amiodarone dose (mg) administered for POAF management during the first 14 postoperative days.
Length of stay in the intensive care unit (ICU)
Duration (days) of ICU hospitalization from the date of surgery until discharge from the intensive care unit.
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