This is a single-center, prospective, randomized, open-label, assessor-blinded, blank-controlled exploratory (pilot) trial evaluating the feasibility of oral colchicine after coronary artery bypass grafting (CABG). Graft failure and cardiovascular events remain common after CABG, and the anti-inflammatory drug colchicine has shown cardiovascular benefit in chronic coronary disease but has not been adequately studied after CABG. Approximately 100 adults (aged 18 years and older, any sex) who have undergone first-time isolated CABG, are clinically stable within 3 days after surgery, and are able to take oral medications will be enrolled. Participants will be randomized 1:1 to receive oral colchicine 0.5 mg once daily, initiated within 3 days after surgery and continued for up to 1 year, or no colchicine (blank control). The primary objective is to assess the feasibility of oral colchicine after CABG, including participant recruitment rate, informed consent rate, treatment adherence, 1-year follow-up completion rate (coronary CT angiography review rate), and safety acceptability, to provide feasibility evidence and sample size estimation parameters for a future multicenter confirmatory randomized controlled trial. Secondary and exploratory objectives include preliminary comparisons of 1-year graft failure (Fitzgibbon B/S/O grades), major adverse cardiovascular events (MACE-5), serious complications of interest, new-onset perioperative atrial fibrillation/flutter, changes in high-sensitivity C-reactive protein and neutrophil-to-lymphocyte ratio, and the incidence of diarrhea and serious infection. Each participant will be followed for 1 year after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Oral Colchicine 0.5mg qd for 1 year
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGParticipant recruitment rate
Average number of participants randomized per month, from start of enrollment to completion of enrollment. Go/no-go (traffic-light) thresholds: Green ≥12 per month; Amber 7-11 per month; Red \<7 per month.
Time frame: From start of enrollment through completion of enrollment (approximately 1 year)
Informed consent success rate
Number of participants who signed informed consent divided by number screened. Go/no-go (traffic-light) thresholds: Green ≥60% and ≤85%; Amber ≥45%and\<60%; Red \<45% or \>85%.
Time frame: From screening through completion of enrollment (approximately 1 year)
Treatment adherence rate
Proportion of participants who are adherent to the assigned treatment (number of adherent participants divided by total number of participants). Go/no-go (traffic-light) thresholds: Green ≥95%; Amber ≥85%and\<95%; Red \<85%.
Time frame: From randomization through 1 year post-CABG (end of study follow-up)
1-year CCTA follow-up completion rate
Proportion of participants who complete coronary CT angiography (CCTA) graft assessment at 1 year after CABG surgery. Go/no-go (traffic-light) thresholds: Green ≥90%; Amber ≥80% and \<90%; Red \<80%.
Time frame: From randomization through 1 year post-CABG (end of study follow-up)
Safety acceptability
Incidence of colchicine-related serious adverse events (SAEs). Go/no-go (traffic-light) thresholds: Green ≤4%; Amber \>4% and ≤8%; Red \>8%.
Time frame: From randomization through 1 year post-CABG (end of study follow-up)
1-year Graft failure rate
Incidence of graft failure at 1 year after CABG, assessed by coronary CT angiography (CCTA). Graft failure is defined as modified Fitzgibbon Grade B (stenosis ≥50%), Grade S (string sign), or Grade O (occlusion).
Time frame: at 1 year post-CABG
The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)
MACE-5 is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and rehospitalization due to unstable angina.
Time frame: within 1 year post-CABG
30-days incidence of serious complications
Incidence of pre-specified serious complications within 30 days after surgery, including: cardiac arrest (requiring cardiopulmonary resuscitation); reoperation (bleeding-related or other causes); incision complications (superficial or deep); pulmonary infection (requiring prolonged or escalated antibiotic therapy); respiratory failure (requiring re-intubation or tracheostomy); permanent pacemaker implantation; major gastrointestinal bleeding; and new-onset renal failure (requiring dialysis).
Time frame: Within 30 days after surgery
1-week new perioperative atrial fibrillationat (PAF) rate
PAF will be detected through continuous electrocardiographic monitoring.
Time frame: within 7 days post-CABG
Change in high-sensitivity C-reactive protein (hs-CRP) and neutrophil-to-lymphocyte ratio (NLR)
Changes in hs-CRP and NLR from baseline at 7 days, 30 days, 6 months, and 12 months after surgery, reported as absolute change and percentage change from baseline.
Time frame: Baseline through 1 year post-CABG
Incidence of diarrhea and serious infection
Incidence of diarrhea (drug-related change in bowel habits, such as increased frequency or loose stools) and serious infection (infection confirmed by microbiological, pathological, and/or imaging examination and requiring intravenous antibiotics) within 1 year after surgery.
Time frame: Within 1 year post-CABG
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