CAD - Coronary Artery Disease, CABG, Colchicine
Conditions
Brief 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.
Interventions
DRUGColchicine 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.
DRUGPlacebo
Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
CONTACTXiaoli Liu, PhD, MD
Outcome results
None listed