Pilot Trial of Colchicine for Graft Failure in CABG

Condition(s) studied

Investigational drug(s) / intervention(s)

Colchicine: Oral Colchicine 0.5mg qd for 1 year

Study summary

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.

Eligibility

Primary outcome measure(s)

• Participant recruitment rate — From start of enrollment through completion of enrollment (approximately 1 year)
  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.
• Informed consent success rate — From screening through completion of enrollment (approximately 1 year)
  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%.
• Treatment adherence rate — From randomization through 1 year post-CABG (end of study follow-up)
  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%.
• 1-year CCTA follow-up completion rate — From randomization through 1 year post-CABG (end of study follow-up)
  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%.
• Safety acceptability — From randomization through 1 year post-CABG (end of study follow-up)
  Incidence of colchicine-related serious adverse events (SAEs). Go/no-go (traffic-light) thresholds: Green ≤4%; Amber \>4% and ≤8%; Red \>8%.

Trial sites (1)

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