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NCT Number: NCT07569328

Low-dose Colchicine for CABG Graft Failure Prevention

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be male or female, aged 18 years or older;
  • Within 3 days after successful isolated coronary artery bypass grafting (CABG);
  • Sign informed consent;

Exclusion criteria

  • Severe valvular heart disease requiring concomitant or staged valvular surgery;
  • History of non-skin cancer in the past 3 years;
  • Inflammatory bowel disease or chronic diarrhea;
  • 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);
  • 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);
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (based on the CKDEPI formula);
  • 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);
  • Decline in cognitive function due to inability to perform basic activities of daily living independently;
  • Drug or alcohol abuse;
  • Other immunosuppressive therapies already in existence or planned;
  • Other causes require long-term colchicine treatment;
  • History of clear or suspected colchicine allergy;
  • 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.

Treatment and study plan

Colchicine Pill

Drug

Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

Other names: Colchicine 0.5 MG

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.

Primary outcomes

  1. graft failure rate

    Time frame: 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

  1. MACCE

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Liu, PhD, MD

CONTACT

[email protected]

8613581633895

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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