This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
622
Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
graft failure rate
At 24 months postoperatively, all patients who complete the study will undergo coronary computed tomographic angiography (CCTA) to assess graft patency, calculated as 1 minus graft failure rate, where graft failure rate = (number of grafts graded B or O according to the Fitzgibbon classification / total number of grafts) × 100%.
Time frame: 2 year after randomization
MACCE
Major adverse cardiovascular and cerebrovascular events include cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operating-related) myocardial infarction, readmission for acute coronary syndrome, and Coronary revascularization
Time frame: 2 year after randomization
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