residual inflammatory risk-guided colchicine in elderly trial

Conditions: Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease; Elderly Patients; C-Reactive Protein

Summary: 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.


Eligibility criteria:
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

Keywords: multivessel coronary artery disease percutaneous coronary intervention elderly patients colchicine high sensitive-c reactive protein efficacy and safety