RecruitingPhase 2NCT06590012

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

Prospective, Double-blind, Comparative Randomized Placebo-controlled Multicenter Study Evaluating the Impact of Oral Administration of the Peroral Supplement "Tertinat" with Dosage of 330 Mg/day for Patients with Cardiovascular Diseases, the Cause of Which is Atherosclerosis, on the Background of Standard Treatment.


Sponsor

Institute for Atherosclerosis Research, Russia

Enrollment

556 participants

Start Date

Aug 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Tertinat for people with atheroscleroses, coronary, atherosclerosis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPlacebo

Participants will take the placebo capsules in addition to standard treatment for a year.

DRUGTertinat

Participants will take Tertinat capsules in addition to standard treatment for a year.


Locations(1)

Institute for Atherosclerosis Research

Moscow, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06590012


Related Trials