NCT07569328Not yet recruiting
Low-dose Colchicine for CABG Graft Failure Prevention
Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 622 (estimated)
- First submitted
- 29 Apr 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07569328
What you commit to
- Study type: Interventional
- Planned participants: 622
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe valvular heart disease requiring concomitant or staged valvular surgery;
- Drug or alcohol abuse;
- Other immunosuppressive therapies already in existence or planned;
- 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.
Other illness
- 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);
- History of clear or suspected colchicine allergy;
Lab values
- 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);
Other
- Decline in cognitive function due to inability to perform basic activities of daily living independently;
- Other causes require long-term colchicine treatment;
Who the study is looking for
- Be male or female, aged 18 years or older;
- Within 3 days after successful isolated coronary artery bypass grafting (CABG);
- Sign informed consent;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.