NCT06590012Active, not recruitingPhase 2
SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPY
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.
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1228 (actual)
- First submitted
- 30 Aug 2024
- Start date
- 29 Aug 2024
- Primary completion date
- 15 Jul 2027
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Diseases
- Coronary artery disease
- NCT number
- NCT06590012
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 1228
- From 29 Aug 2024 to the primary completion date, 15 Jul 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology.
- Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.
Other illness
- 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).
- Systemic autoimmune diseases in medical history, including: rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, autoimmune vasculitis, ulcerative colitis.
- Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).
- Carriers of HIV or viral hepatitis
Lab values
- 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)
Other
- Pregnancy or breast feeding
- Refusal to participate in the study / to sigh informed concent.
Who the study is looking for
- 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.
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center" Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Research Institute for Complex Issues of Cardiovascular Diseases Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| Lipetsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Lipetsk | Russia | Unknown status |
| M. F. Vladimirsky Moscow Regional Research Clinical Institute Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| A. V. Vishnevsky National Medical Research Center of Surgery (Federal State Budgetary Institution) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| LLC RC Medical Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| City Polyclinic No. 109 (State Budgetary Healthcare Institution) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Llc "Sfera-Med" Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Cardiology Research Institute - Branch of the Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences" Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| N. N. Burdenko Voronezh State Medical University Coordinator of this site? Confirm its status | Voronezh | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.