Low-dose Colchicine for CABG Graft Failure Prevention

NCT07569328 — Not applicable, Not yet recruiting, 622 participants, Beijing Anzhen Hospital

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Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial

RegistryNCT07569328
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment622 (Estimated)
SponsorBeijing Anzhen Hospital (Other)
ConditionsCAD - Coronary Artery Disease, CABG, Colchicine
InterventionsColchicine Pill, Placebo (Drug)
Datesstart 2026-09-01 (estimated), primary completion 2028-09-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-05-06, last updated 2026-05-06
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for CAD - Coronary Artery Disease All trials for CABG All trials of Colchicine Pill All trials of Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Colchicine groupExperimentalDrug: Colchicine PillPatients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus colchicine (0.5 mg qd) starting as soon as possible (within 24 hours) and continuing for 24 months.
Placebo groupPlacebo comparatorDrug: PlaceboPatients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus matching placebo (1 tablet qd) starting as soon as possible (within 24 hours) and continuing for 24 months.
  • Colchicine Pill (Drug), also known as Colchicine 0.5 MG: 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 (Drug): Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

+Outcome measures

Primary outcomes

  • 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%.

Secondary outcomes

  • MACCE [2 year after randomization]: Major adverse cardiovascular and cerebrovascular events include cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operating-related) myocardial infarction, readmission for acute coronary syndrome, and Coronary revascularization

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Anzhen HospitalBeijing, Beijing MunicipalityChina