Colchicine Pill: 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: Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Be male or female, aged 18 years or older;
2. Within 3 days after successful isolated coronary artery bypass grafting (CABG);
3. Sign informed consent;
Exclusion Criteria:
1. Severe valvular heart disease requiring concomitant or staged valvular surgery;
2. History of non-skin cancer in the past 3 years;
3. Inflammatory bowel disease or chronic diarrhea;
4. Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
5. Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities (Hemoglobin \<100g/L or hematocrit \< 30% or \> 52% or white blood cell count \< 3×109/L or platelet count \< 100×109/L);
6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (based on the CKDEPI formula);
7. Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range, accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders (INR\>1.5) (except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);
8. Decline in cognitive function due to inability to perform basic activities of daily living independently;
9. Drug or alcohol abuse;
10. Other immunosuppressive therapies already in existence or planned;
11. Other causes require long-term colchicine treatment;
12. History of clear or suspected colchicine allergy;
13. Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.
Primary outcome measure(s)
graft failure rate — 2 year after randomization 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%.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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