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ACTIVE NOT RECRUITING
NCT06590012
PHASE2

SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPY

Sponsor: Institute for Atherosclerosis Research, Russia

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Double-Blinded Randomized Placebo-controlled Multicenter Study Evaluating the Impact of Dietary Supplement "Tertinat" on Major Adverse Cardiovascular Events in ATherosclerotic Patients After Coronary Revascularization Surgery.

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1228

Start Date

2024-08-29

Completion Date

2027-08-31

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DRUG

Placebo

Participants will take the placebo capsules in addition to standard treatment for 2 years.

DRUG

Tertinat

Participants will take Tertinat capsules in addition to standard treatment for 2 years.

Locations (10)

State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"

Kazan', Russia

Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, Russia

Lipetsk Regional Clinical Hospital

Lipetsk, Russia

A. V. Vishnevsky National Medical Research Center of Surgery (Federal State Budgetary Institution)

Moscow, Russia

M. F. Vladimirsky Moscow Regional Research Clinical Institute

Moscow, Russia

LLC "RC Medical"

Novosibirsk, Russia

City Polyclinic No. 109 (State Budgetary Healthcare Institution)

Saint Petersburg, Russia

Llc "Sfera-Med"

Saint Petersburg, Russia

Cardiology Research Institute - Branch of the Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

Tomsk, Russia

N. N. Burdenko Voronezh State Medical University

Voronezh, Russia