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

2023-GSP-GG-40

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.

2023-09-01

2025-09-01

2025-10-01

Not yet recruiting

Early phase I

800

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, Two-arm, Randomized, Superiority Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}

2023-09-06