This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
Age 18 years and older
Coronary artery bypass graft (CABG) planned procedure
History of atrial fibrillation
Off-pump CABG procedure
Current treatment with colchicine for any cause
Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)
Parallel
Colchicine (Colcrys®)
DrugColchicine dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl \>30 mL/min: Colchicine 0.6 mg twice daily If CrCl \<30 mL/min: Colchicine 0.3 mg once daily For patients weighing \<70 kg: If CrCl \>30 mL/min: Colchicine 0.6 mg once daily If CrCl \<30 mL/min: Colchicine 0.3 mg every other day
Placebo
DrugPlacebo dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl \>30 mL/min: Placebo 0.6 mg twice daily If CrCl \<30 mL/min: Placebo 0.3 mg once daily For patients weighing \<70 kg: If CrCl \>30 mL/min: Placebo 0.6 mg once daily If CrCl \<30 mL/min: Placebo 0.3 mg every other day
Change in Inflammatory markers
markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays.
Rate of post-operative atrial fibrillation (POAF)
Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.
Number of participants discontinuing treatment
treatment discontinuation rates due to adverse events will be measured
Change in Liver Function
Assessed as the impact on clinical biomarkers, i.e., ALT, AST in units per liter.
Change in creatinine level
Assessed as the impact on clinical biomarkers, i.e., creatinine level in mg/dl
Creatine kinase level
Assessed as the impact on clinical biomarkers, creatine kinase (i.e., CK level) in units per liter
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Ayesha Ather
Lead sponsor
University of Kentucky
Sponsor institution
