Actively Recruiting

Phase 2
Age: 45Years - 75Years
All Genders
ID06590012

Study of Oral Supplement Tertinat 330 Mg/day for Adults With Atherosclerosis-Related Cardiovascular Diseases Alongside Standard Treatment

Led by Institute for Atherosclerosis Research, Russia · Updated on 2024-09-19

556

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of the biologically active food supplement Tertinat on the progression of atherosclerosis and treatment outcomes in adults with cardiovascular diseases caused by atherosclerosis. The study aims to monitor the frequency of fatal and significant cardiovascular events every 12 months after participants join. It will also examine how Tertinat affects pro-atherogenic changes in lipoproteins and inflammatory activity by measuring specific blood markers. Participants will receive either daily Tertinat capsules or a matching placebo for 24 months, alongside their standard medical treatment. The study is randomized and triple-blind, comparing the supplement to placebo to assess its impact on cardiovascular health. Annual clinic visits will include check-ups and testing to track progress. During the trial, participants will have blood tests to evaluate lipid profiles, inflammatory markers, and other cardiovascular indicators. Ultrasound examinations will assess artery stenosis severity. Researchers will monitor adherence, record cardiovascular events, and evaluate safety throughout the study. The primary outcomes focus on fatal and clinically significant cardiovascular events within 12 months following revascularization interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 45 to 75 years
  • Diagnosed with cardiovascular disease caused by atherosclerosis requiring hospitalization and treatment
  • Conditions may include coronary heart disease or atherosclerotic lesions needing surgical revascularization
  • Completed necessary diagnostic tests such as ECG, ultrasound, CT, or angiography
  • Blood tests done for cholesterol, triglycerides, lipoproteins, and glucose
  • Able to attend yearly follow-up visits
  • Signed informed consent to participate
Not Eligible

You will not qualify if you...

  • Critical cardiovascular conditions including stage III-IV tissue ischemia, stroke, acute coronary syndrome, myocardial infarction, and severe heart failure (NYHA class III-IV)
  • Other urgent conditions like advanced chronic renal failure
  • History of systemic autoimmune diseases such as rheumatoid arthritis, lupus, autoimmune thyroiditis, vasculitis, or ulcerative colitis
  • Unexplained significant weight loss over 10% in the past year
  • Conditions limiting study participation like dementia, psychiatric disorders, drug addiction, or alcoholism
  • Participation in other clinical trials or use of investigational drugs within 3 months before enrollment
  • Carriers of HIV or viral hepatitis
  • Pregnancy or breastfeeding
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants take either Tertinat or placebo capsules alongside their standard treatment for cardiovascular disease.

Approximately monthly visits for medication dispensing and health monitoring

Follow-up

Duration - Up to 12 months following treatment

Participants are monitored for cardiovascular events and changes in health status after completing treatment.

Yearly visits for health evaluation

Trial Site Locations

Total: 1 location

1

Institute for Atherosclerosis Research

Moscow, Russia, 121609

Actively Recruiting

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Research Team

N

Nikolay Shakhpazyan, PhD; Dr.

A

Alikhan Asoyan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Proatherogenic Sialidases and Desialylated Lipoproteins: 35 Years of Research and Current State from Bench to Bedside.

Alexandre Mezentsev, Evgeny Bezsonov, Dmitry Kashirskikh...

https://pubmed.ncbi.nlm.nih.gov/34070542

Effect of Curcumin on Glycaemic and Lipid Parameters in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Luis E Simental-Mendía, Najeeb Shah, Thozhukat Sathyapalan...

https://pubmed.ncbi.nlm.nih.gov/34655047

The Anti-atherosclerotic Effects of Natural Polysaccharides: From Phenomena to the Main Mechanisms of Action.

Vasily P Karagodin, Volha I Summerhill, Shaw-Fang Yet...

https://pubmed.ncbi.nlm.nih.gov/35585810

Potential Application of the Plant-Derived Essential Oils for Atherosclerosis Treatment: Molecular Mechanisms and Therapeutic Potential.

Siarhei A Dabravolski, Vasily N Sukhorukov, Alexandra A Melnichenko...

https://pubmed.ncbi.nlm.nih.gov/37570643