NCT06590012

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Institute for Atherosclerosis Research, Russia · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Atheroscleroses, Coronary
• Carotid Atherosclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Participants will take the placebo capsules in addition to standard treatment for a year.
DRUG	Tertinat	Participants will take Tertinat capsules in addition to standard treatment for a year.

Timeline

• Start date: 2024-08-29
• Primary completion: 2025-08-29
• Completion: 2026-03-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Russia