🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07569328
Starting soon Not applicable

Low-dose Colchicine for CABG Graft Failure Prevention

NCT07569328 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Anzhen Hospital
Phase
Not applicable
Started
2026-09-01
Last updated
2026-05-06

Condition(s) studied

CAD - Coronary Artery DiseaseCABGColchicine

Investigational drug(s) / intervention(s)

Colchicine PillPlacebo

Colchicine 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.

Placebo: Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital Beijing Beijing Municipality

More Beijing Anzhen Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07569328 on ClinicalTrials.gov ↗ ← All trials in China