CABG, Colchicine, Graft Failure
Conditions
Brief 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.
Interventions
DRUGColchicine
Oral Colchicine 0.5mg qd for 1 year
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years old， * Any sex， * Signed informed consent， * Within 3 days after a successful isolated CABG
Exclusion criteria
* Allergy, * Hematopoietic dysfunction, * Moderate to severe hepatic dysfunction, * Moderate to severe renal dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diarrhea and serious infection | Within 1 year post-CABG | 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. |
| Change in high-sensitivity C-reactive protein (hs-CRP) and neutrophil-to-lymphocyte ratio (NLR) | Baseline through 1 year post-CABG | 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. |
| 1-year Graft failure rate | at 1 year post-CABG | 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). |
| The time to first 5-point Major Adverse Cardiovascular Event (MACE-5) | within 1 year post-CABG | MACE-5 is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and rehospitalization due to unstable angina. |
| 30-days incidence of serious complications | Within 30 days after surgery | 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). |
| 1-week new perioperative atrial fibrillationat (PAF) rate | within 7 days post-CABG | PAF will be detected through continuous electrocardiographic monitoring. |
Countries
China
Contacts
CONTACTYunpeng Zhu, MD
STUDY_CHAIRQiang Zhao, MD
Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
PRINCIPAL_INVESTIGATORYunpeng Zhu, MD
Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
Outcome results
None listed