Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial
| Registry | NCT07569328 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 622 (Estimated) |
| Sponsor | Beijing Anzhen Hospital (Other) |
| Conditions | CAD - Coronary Artery Disease, CABG, Colchicine |
| Interventions | Colchicine Pill, Placebo (Drug) |
| Dates | start 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 |
| Locations | 1 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine Pill | Patients 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 group | Placebo comparator | Drug: Placebo | Patients 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. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Anzhen Hospital | Beijing, Beijing Municipality | China |