Atherosclerosis Clinical Trials

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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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with cardiovascular disease disease of atherosclerotic origin, requiring hospitalization and treatment hospital conditions. Cardiovascular diseases may include the following nosology: Coronary heart disease; Atherosclerosis. Diseases include (and/or) atherosclerotic lesions of the coronary arteries, brachiocephalic arteries, limb arteries, renal arteries requiring surgical revascularization.

• Patients who have undergone a complex of necessary by current standards for their disease instrumental and laboratory examinations, including ECG, severity assessment vascular stenosis (ultrasound, CT, angiography), including large arteries, brachiocephalic arteries, femoral arteries, biochemical blood test assessing the level of general cholesterol, triglycerides, lipoproteins low density, high lipoprotein density, glucose level.

• Possibility of monitoring the patient - Possibility every 12 months call the patient for questioning and examination.

• The patient has signed informed consent.

Locations
Other Locations
Russian Federation
Institute for Atherosclerosis Research
RECRUITING
Moscow
Contact Information
Primary
Nikolay Shakhpazyan, PhD; Dr.
nshakhpazyan@gmail.com
+79168244496
Backup
Alikhan Asoyan
+79772667620
Time Frame
Start Date: 2024-08-29
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 556
Treatments
Experimental: Tertinat
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Institute for Atherosclerosis Research, Russia

This content was sourced from clinicaltrials.gov