Evaluating the effects of Tertinat on cardiovascular diseases related to atherosclerosis
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.
This study is testing if a new supplement called Tertinat can help people with heart problems related to atherosclerosis feel better and have fewer health issues over a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 556 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Institute for Atherosclerosis Research, Russia Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06590012 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of the biologically active food supplement Tertinat on the progression of atherosclerosis and treatment outcomes in patients with cardiovascular diseases. Participants will receive either Tertinat or a placebo, with their health monitored for significant cardiovascular events over a 12-month period. The study will also evaluate Tertinat's effects on lipoprotein modification and inflammatory markers in the blood, alongside standard therapy for their conditions.
Who should consider this trial
Good fit: Ideal candidates include adults with cardiovascular diseases of atherosclerotic origin who require hospitalization and treatment.
Not a fit: Patients without atherosclerosis-related cardiovascular diseases or those not requiring hospitalization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary supplement option to improve cardiovascular health and slow the progression of atherosclerosis.
How similar studies have performed: While there have been studies on dietary supplements for cardiovascular health, the specific approach of using Tertinat in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Critical and urgent cardiovascular conditions: tissue ischemia stage III-IV, stroke, acute coronary syndrome, myocardial infarction, chronic heart failure III and IV class NYHA (New York Heart Association). * Other critical and urgent conditions not associated with cardiovascular diseases, including the need for urgent interventions, chronic renal failure stages IV-V (creatinine clearance \< 30 ml / min according to the Cockcroft-Gault Equation) * Systemic autoimmune diseases in medical history, including: rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, autoimmune vasculitis, ulcerative colitis. * Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology. * Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.). * Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry. * Carriers of HIV or viral hepatitis * Pregnancy or breast feeding * Refusal to participate in the study.
Where this trial is running
Moscow
- Institute for Atherosclerosis Research — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Nikolay Shakhpazyan, PhD; Dr.
- Email: nshakhpazyan@gmail.com
- Phone: +79168244496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.