Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
NCT ID: NCT06590012
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
556 participants
INTERVENTIONAL
2024-08-29
2026-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tertinat
Tertinat
Participants will take Tertinat capsules in addition to standard treatment for a year.
Placebo
Placebo
Participants will take the placebo capsules in addition to standard treatment for a year.
Interventions
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Placebo
Participants will take the placebo capsules in addition to standard treatment for a year.
Tertinat
Participants will take Tertinat capsules in addition to standard treatment for a year.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
75 Years
ALL
No
Sponsors
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Institute for Atherosclerosis Research, Russia
OTHER
Responsible Party
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Locations
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Institute for Atherosclerosis Research
Moscow, , Russia
Countries
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Central Contacts
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Alikhan Asoyan
Role: CONTACT
Facility Contacts
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Alexander N Orekhov, PhD, DSc
Role: backup
Nikita G Nikiforov, BSc
Role: backup
References
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Mezentsev A, Bezsonov E, Kashirskikh D, Baig MS, Eid AH, Orekhov A. Proatherogenic Sialidases and Desialylated Lipoproteins: 35 Years of Research and Current State from Bench to Bedside. Biomedicines. 2021 May 25;9(6):600. doi: 10.3390/biomedicines9060600.
Liu Y, Zhang H, Dai X, Zhu R, Chen B, Xia B, Ye Z, Zhao D, Gao S, Orekhov AN, Zhang D, Wang L, Guo S. A comprehensive review on the phytochemistry, pharmacokinetics, and antidiabetic effect of Ginseng. Phytomedicine. 2021 Nov;92:153717. doi: 10.1016/j.phymed.2021.153717. Epub 2021 Sep 10.
Simental-Mendia LE, Shah N, Sathyapalan T, Majeed M, Orekhov AN, Jamialahmadi T, Sahebkar A. Effect of Curcumin on Glycaemic and Lipid Parameters in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Reprod Sci. 2022 Nov;29(11):3124-3133. doi: 10.1007/s43032-021-00761-6. Epub 2021 Oct 15.
P Karagodin V, I Summerhill V, Yet SF, Orekhov AN. The Anti-atherosclerotic Effects of Natural Polysaccharides: From Phenomena to the Main Mechanisms of Action. Curr Pharm Des. 2022;28(22):1823-1832. doi: 10.2174/1381612828666220518095025.
Glanz V, Bezsonov EE, Soldatov V, Orekhov AN. Thirty-Five-Year History of Desialylated Lipoproteins Discovered by Vladimir Tertov. Biomedicines. 2022 May 19;10(5):1174. doi: 10.3390/biomedicines10051174.
Markina YV, Kirichenko TV, Markin AM, Yudina IY, Starodubova AV, Sobenin IA, Orekhov AN. Atheroprotective Effects of Glycyrrhiza glabra L. Molecules. 2022 Jul 22;27(15):4697. doi: 10.3390/molecules27154697.
Hassanizadeh S, Shojaei M, Bagherniya M, Orekhov AN, Sahebkar A. Effect of nano-curcumin on various diseases: A comprehensive review of clinical trials. Biofactors. 2023 May-Jun;49(3):512-533. doi: 10.1002/biof.1932. Epub 2023 Jan 6.
Dabravolski SA, Sukhorukov VN, Melnichenko AA, Khotina VA, Orekhov AN. Oligosaccharides as Potential Therapeutics against Atherosclerosis. Molecules. 2023 Jul 17;28(14):5452. doi: 10.3390/molecules28145452.
Dabravolski SA, Sukhorukov VN, Melnichenko AA, Khotina VA, Orekhov AN. Potential Application of the Plant-Derived Essential Oils for Atherosclerosis Treatment: Molecular Mechanisms and Therapeutic Potential. Molecules. 2023 Jul 26;28(15):5673. doi: 10.3390/molecules28155673.
Poznyak AV, Kashirskikh DA, Postnov AY, Popov MA, Sukhorukov VN, Orekhov AN. Sialic acid as the potential link between lipid metabolism and inflammation in the pathogenesis of atherosclerosis. Braz J Med Biol Res. 2023 Dec 11;56:e12972. doi: 10.1590/1414-431X2023e12972. eCollection 2023.
Orekhov A, Sukhorukov V, Melnichenko A. Is Oxidized Low-Density Lipoprotein a Principal Actor in Atherogenesis? Curr Med Chem. 2024;31(42):6909-6910. doi: 10.2174/0109298673283640231208103306. No abstract available.
Orekhov A, Khotina V, Sukhorukov V, Sobenin I. Non-oxidative vs Oxidative Forms of Modified Low-density Lipoprotein: What is More Important in Atherogenesis? Curr Med Chem. 2024;31(17):2309-2313. doi: 10.2174/0109298673294245240102105814. No abstract available.
Orekhov AN. We Must Abandon the Myth: Oxidized Low-density Lipoprotein is not a Lipoprotein that Plays a Key Role in Atherogenesis. Curr Med Chem. 2025;32(15):2899-2914. doi: 10.2174/0109298673301236240311113807.
Poznyak AV, Yakovlev AA, Popov Mcapital A, Cyrillic, Zhuravlev AD, Sukhorukov VN, Orekhov AN. WITHDRAWN: Coronary atherosclerotic plaque regression strategies. J Biomed Res. 2024 May 29:1-21. doi: 10.7555/JBR.37.20230223. Online ahead of print.
Kashirskikh D, Chicherina N, Glanz V, Orekhov A, Sobenin I. Mouse Model of Low-density Lipoprotein Desialylation In Vivo. Curr Med Chem. 2024 May 31. doi: 10.2174/0109298673294745240528092506. Online ahead of print.
Other Identifiers
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Ter-07082024
Identifier Type: -
Identifier Source: org_study_id
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