Pilot Trial of Colchicine for Graft Failure in CABG
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old，
Any sex，
Signed informed consent，
Within 3 days after a successful isolated CABG
Disqualifiers
Allergy,
Hematopoietic dysfunction,
Moderate to severe hepatic dysfunction,
Moderate to severe renal dysfunction.
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine
DrugOral Colchicine 0.5mg qd for 1 year
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ColchicineExperimental treatment 1 intervention
Group B: Blank controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Participant 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)2
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)3
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)4
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)Secondary outcomes
1
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-CABG2
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-CABG3
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 surgery4
1-week new perioperative atrial fibrillationat (PAF) rate
PAF will be detected through continuous electrocardiographic monitoring.
Time frame
within 7 days post-CABGSponsors and contacts
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Source ClinicalTrials.gov