Actively Recruiting
Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
Led by Institute for Atherosclerosis Research, Russia · Updated on 2024-09-19
556
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 45 to 75 years
- Diagnosed with cardiovascular disease caused by atherosclerosis requiring hospitalization and treatment
- May have coronary heart disease or atherosclerotic lesions in coronary, brachiocephalic, limb, or renal arteries needing surgical revascularization
- Completed required examinations including ECG, vascular stenosis assessment (ultrasound, CT, angiography), and blood tests for cholesterol, triglycerides, lipoproteins, and glucose
- Able to be monitored yearly for questioning and examination
- Signed informed consent to participate in the trial
You will not qualify if you...
- Critical or urgent cardiovascular conditions such as stage III-IV tissue ischemia, stroke, acute coronary syndrome, myocardial infarction, or chronic heart failure class III-IV NYHA
- Other urgent conditions requiring interventions, including chronic renal failure stages IV-V with creatinine clearance less than 30 ml/min
- History of systemic autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, autoimmune vasculitis, or ulcerative colitis
- Significant unexplained weight loss over 10% in the past year
- Conditions that impair study participation such as dementia, neuropsychiatric diseases, drug addiction, or alcoholism
- Participation in other clinical studies or investigational drug use within 3 months prior
- Carriers of HIV or viral hepatitis
- Pregnancy or breastfeeding
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute for Atherosclerosis Research
Moscow, Russia, 121609
Actively Recruiting
Research Team
N
Nikolay Shakhpazyan, PhD; Dr.
CONTACT
A
Alikhan Asoyan
CONTACT
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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