Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases

Phase 2

Recruiting

• Conditions: Atherosclerosis; Atheroscleroses, Coronary; Carotid Atherosclerosis
• Interventions: Drug: Tertinat; Drug: Placebo

• Registration Number: NCT06590012
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

Brief Summary

The aim of this clinical trial is to evaluate whether the biologically active food supplement, Tertinat, can influence atherosclerosis progression in adults and improve the treatment outcomes of cardiovascular diseases. The study will assess the frequency of fatal and clinically significant cardiovascular events, monitored every 12 months following participants\' inclusion in the trial.

Additionally, the trial will evaluate Tertinat's ability to prevent pro-atherogenic modification of lipoproteins and its impact on inflammatory activity. To this end, levels of desialylated low-density lipoproteins (LDL) and inflammatory markers in the blood will be monitored. Tertinat administration will occur alongside the standard therapy prescribed to patients based on their existing medical conditions.

Researchers will compare the effects of the Tertinat supplement to a placebo (an identical-looking substance that does not contain the active supplement) to determine if Tertinat is effective in reducing cardiovascular events .

Participants will:

Take either Tertinat or a placebo daily for a duration of 24 months. Visit the clinic once a year for check-ups and testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Study First Submitted: 2024-08-30
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Primary Completion: 2025-08-29
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Patients with cardiovascular disease disease of atherosclerotic origin, requiring hospitalization and treatment hospital conditions. Cardiovascular diseases may include the following nosology: Coronary heart disease; Atherosclerosis. Diseases include (and/or) atherosclerotic lesions of the coronary arteries, brachiocephalic arteries, limb arteries, renal arteries requiring surgical revascularization.
• Patients who have undergone a complex of necessary by current standards for their disease instrumental and laboratory examinations, including ECG, severity assessment vascular stenosis (ultrasound, CT, angiography), including large arteries, brachiocephalic arteries, femoral arteries, biochemical blood test assessing the level of general cholesterol, triglycerides, lipoproteins low density, high lipoprotein density, glucose level.
• Possibility of monitoring the patient - Possibility every 12 months call the patient for questioning and examination.
• The patient has signed informed consent.

Exclusion Criteria

• Critical and urgent cardiovascular conditions: tissue ischemia stage III-IV, stroke, acute coronary syndrome, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tertinat	Tertinat	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Frequency of fatal cardiovascular events	Evaluated in 12 months from revascularization interventions	Fatal cardiovascular events include: death from myocardial infarction, other forms of coronary heart disease (CHD), stroke, including sudden death and death within 24 hours of symptom onset, death from other non-coronary cardiovascular diseases except definitely non-atherosclerotic causes of death.
Frequency of clinically significant cardiovascular events	Evaluated in 12 months from revascularization interventions	Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure, hospitalization due to critical limb ischemia.

Secondary Outcome Measures

Name	Time	Method
Change in the severity of stenosis of the affected due to the underlying disease and/or carotid and femoral arteries according to ultrasound examination	Evaluated in 12 months
Atherogenicity changes in serum blood	Evaluated in 12 months
Changes in LDL sialic acid levels	Evaluated in 12 months
Changes in lipid profile indicators (total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol - calculated value)	Evaluated in 12 months
Changes in circulating immune complex cholesterol levels	Evaluated in 12 months

Trial Locations

Locations (1)

Institute for Atherosclerosis Research; 🇷🇺 Moscow, Russian Federation