Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-01-17 @ 7:44 PM
Study NCT ID:
NCT06590012
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
Sponsor:
Institute for Atherosclerosis Research, Russia
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERACAD
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: