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

Institute for Atherosclerosis Research, Russia

Status and phase: Enrolling; Phase 2

Conditions: Carotid Atherosclerosis; Atheroscleroses, Coronary; Atherosclerosis

Treatments: Drug: Placebo; Drug: Tertinat

Study type: Interventional

Funder types: Other

Identifiers

NCT06590012

Ter-07082024

Details and patient eligibility

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.

Enrollment: 556 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

556 participants in 2 patient groups, including a placebo group

Tertinat

Experimental group

Treatment:

Drug: Tertinat

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo