Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Efficacy and Safety of Residual Inflammatory Risk-Guided Low-dose Colchicine Therapy in Elderly Patients With Multivessel Coronary Artery Disease: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions it aims to answer are:

• Whether the intervention is effective in reducing ischemic events
• Whether the intervention is effective in reducing inflammatory biomarkers' level
• Whether the intervention is safe for elderly patients

Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no specific intervention for one year. Patients enrolled should complete one-year follow-up in the form of clinic visit or telephone call.

Inclusion Criteria:

• Aged 60-80 years old
• Baseline plasma hs-CRP≥2 mg/L
• Hospitalized patients with coronary artery disease with multi-vessel lesions (multi-vessel lesions are defined as at least 2 major epicardial coronary arteries with ≥50% stenosis in their main branch diameter confirmed by coronary CT or coronary angiography, with or without left main artery disease)
• Patients with myocardial ischemia-related symptoms or objective evidence are successfully treated with PCI, and the condition is relatively stable
• Received standard drug therapies based on their condition at baseline (including antiplatelet, lipid-lowering, blood pressure control, blood glucose control, and other treatments recommended by guidelines)
• Subjects or legal representatives have signed informed consent.

Exclusion Criteria:

• Patients who have acute myocardial infarction within 30 days
• Patients who have taken colchicine and have a clear history of allergy or intolerance
• Patients with renal insufficiency, eGFR <30 ml/min/1.73 m^2 (calculated by MDRD formula) or blood creatinine levels exceeding 2 times the upper normal limit
• Patients with cirrhosis, chronic active hepatitis, liver function impairment (alanine aminotransferase exceeding 3 times the upper normal limit or total bilirubin exceeding 2 times the upper normal limit) or cholestasis
• Patients with a known history of hypomyelodysplasia
• Patients with heart failure (NYHA Class III-IV) or severe valvular disease
• Patients with concomitant neoplastic or cancer disease
• Patients with chronic obstructive pulmonary disease or other chronic pulmonary disease
• Patients with poorly controlled disease, such as current cardiogenic shock, hemodynamic instability, heart failure (NYHA Class III-IV), left ventricular ejection fraction less than 35%, recent stroke (within the past 3 months), or any other condition in which the investigator believes that participation in this study puts the patient at risk
• Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
• Patients with hemoglobin less than 115 g/L, white blood cell count less than 4.0*10^9/L, or platelet count less than 110*10^9/L
• Patients are currently using or plan to begin chronic systemic steroid therapy (oral or intravenous) during the study period (topical or inhaled steroids are allowed)
• Patients with acute inflammation or viral infection
• Female patients who are currently pregnant, planning to become pregnant, or breastfeeding