Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial

Inclusion criteria

• The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing any protocol-specified examinations or procedures;
• Aged ≥18 years;
• Clinically diagnosed with chronic coronary syndrome (CCS);
• CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) >0.80.

Exclusion criteria

• Unable or unwilling to provide informed consent;
• Unable to complete scheduled follow-up;
• Underwent PCI within the past 3 months;
• History of coronary artery bypass grafting (CABG);
• Diagnosis of acute coronary syndromes (ACS);
• No coronary plaque or plaque stenosis <50% (confirmed by CCTA);
• Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery;
• Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea;
• History of gastric ulcer or gastric bleeding;
• Pregnant/lactating women or women of childbearing age without effective contraception;
• Neuromuscular disease or non-transient creatine kinase (CK) >3×upper limit of normal (ULN) (confirmed by ≥2 lab tests);
• Clinically significant non-transient hematological abnormalities (hemoglobin <100 g/L, hematocrit <30%/ >52%, white blood cell count <3×10⁹/L, platelet count <100×10⁹/L; confirmed by ≥2 lab tests);
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² (CKD-EPI formula);
• Liver dysfunction (alanine aminotransferase >3×ULN and/or total bilirubin >2×ULN);
• Current/planned immunosuppressive therapy;
• Long-term colchicine use for other indications;
• Definite/suspected colchicine allergy;
• Active malignant tumor (expected survival <1 year);
• Use of potent CYP3A4/P-glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin, clarithromycin) without alternative drugs.