NCT06590012 Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
| NCT ID | NCT06590012 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute for Atherosclerosis Research, Russia |
| Condition | Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2025-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 556 participants in total. It began in 2024-08-29 with a primary completion date of 2025-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06590012 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06590012 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06590012 currently recruiting?
Yes, NCT06590012 is actively recruiting participants. Contact the research team at nshakhpazyan@gmail.com for enrollment information.
Where is the NCT06590012 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06590012 clinical trial?
NCT06590012 is sponsored by Institute for Atherosclerosis Research, Russia. The trial plans to enroll 556 participants.