SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPY

The aim of this double-blind, randomized, placebo-controlled, multicenter study is to evaluate the pathogenetic effects of the dietary supplement "Tertinat" on a fundamental mechanism of atherosclerosis development: its ability to inhibit pathological desialylation of low-density lipoproteins (LDL). According to the protocol's scientific hypothesis, the loss of sialic acid from the surface of LDL converts them into highly atherogenic particles, which are actively captured by vascular macrophages, triggering the formation of unstable atherosclerotic plaques. Over 24 months of daily administration of 330 mg of epigallocatechin-3-gallate, along with standard therapy, will evaluate not only the incidence of major cardiovascular events (MACE) in atherosclerotic patients who have undergone the procedure of surgical revascularization, but also the direct dynamics of recovery of sialic acid levels in LDL particles in patients' blood. The study aims to confirm that preventing LDL desialylation reduces overall serum atherogenicity, prevents cholesterol accumulation within macrophages in vivo, and thereby provides a proven clinical effect - a reduced risk of myocardial infarction, stroke, unstable angina, heart failure, and the need for repeated revascularization in patients after coronary artery bypass grafting or stenting.

Inclusion Criteria: * Men and women aged 45-75 * Patients with atherosclerotic cardiovascular diseases who have passed revascularization procedure within last 3 months prior to the inclusion in the study * Atherosclerotic cardiovascular diseases may include coronary heart disease, and/or coronary atherosclerosis, and/or atherosclerosis of brachiocephalic / limb / renal arteries. * Patients who have undergone instrumental and laboratory examinations (ECG, ultrasound / CT / angiography, biochemical tests - total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, blood glucose, C-reactive protein), and the data from above examinations from medical records are available. * The principal patient's abitity for follow-up questioning and examination at 12 and 24 months apart from inclusion in the study. * The signed informed consent. Exclusion Criteria: * Critical and urgent cardiovascular conditions: tissue ischemia stage III-IV, stroke, acute coronary syndrome, acute myocardial infarction, chronic heart failure III and IV class NYHA (New York Heart Association). * Other critical and urgent conditions not associated with cardiovascular diseases, including the need for urgent interventions, chronic renal failure stages IV-V (creatinine clearance \< 30 ml / min according to the Cockcroft-Gault Equation) * Systemic autoimmune diseases in medical history, including: rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, autoimmune vasculitis, ulcerative colitis. * Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology. * Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.). * Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry. * Carriers of HIV or viral hepatitis * Pregnancy or breast feeding * Refusal to participate in the study / to sigh informed concent.