Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · Sep 1, 2023

Keywords

ClinConnect Summary

The Residual Inflammatory Risk-Guided Colchicine in Elderly Trial is studying whether a low dose of colchicine, a medication used to reduce inflammation, can help elderly patients (ages 60-80) with certain heart conditions. Specifically, the trial focuses on patients who have a high level of a marker called C-reactive protein (hs-CRP), which indicates inflammation, and who have blockages in multiple blood vessels supplying the heart. The main goals are to see if colchicine can lower the risk of heart-related events, decrease inflammation in the body, and determine if it is safe for older adults.

To participate in this trial, individuals must be between 60 and 80 years old, have been recently hospitalized for heart disease with significant blockages in their blood vessels, and have a specific level of inflammation in their blood. Participants will be randomly assigned to take colchicine daily for one year or to not receive any specific treatment. Throughout the year, participants will have follow-up visits or phone calls to monitor their health. It’s important to note that people with certain health issues or recent serious conditions, such as heart failure or active infections, will not be eligible to join the study.

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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