Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: colchicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, Two-arm, Randomized, Superiority Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine group<br>Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. | Drug: colchicine<br>* Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke | From randomization to occurence of first event, assessed up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death | Number of participants with cardiovascular death. | From randomization to occurence of first event, assessed up to one year | 
| Spontaneous (nonprocedural) myocardial infarction | Number of participants with spontaneous (nonprocedural) myocardial infarction. | From randomization to occurence of first event, assessed up to one year | 
| Ischemia-driven coronary revascularization | Number of participants with ischemia-driven coronary revascularization. | From randomization to occurence of first event, assessed up to one year | 
| Ischemic stroke | Number of participants having had a ischemic stroke. | From randomization to occurence of first event, assessed up to one year | 
| Change of hs-CRP | Change of hs-CRP comparing to the baseline | From randomization to treatment at one month and one year | 
| Change of white blood cell count | Change of white blood cell count comparing to the baseline | From randomization to treatment at one month and one year | 
| Change of neutrophil count | Change of neutrophil count comparing to the baseline | From randomization to treatment at one month and one year | 
| Change of monocyte count | Change of monocyte count comparing to the baseline | From randomization to the end of treatment at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multivessel coronary artery disease, percutaneous coronary intervention, elderly patients, colchicine, high sensitive-C reactive protein, efficacy and safety