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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tertinat | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will take the placebo capsules in addition to standard treatment for a year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of fatal cardiovascular events | Fatal cardiovascular events include: death from myocardial infarction, other forms of coronary heart disease (CHD), stroke, including sudden death and death within 24 hours of symptom onset, death from other non-coronary cardiovascular diseases except definitely non-atherosclerotic causes of death. | Evaluated in 12 months from revascularization interventions |
| Frequency of clinically significant cardiovascular events | Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure, hospitalization due to critical limb ischemia. | Evaluated in 12 months from revascularization interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the severity of stenosis of the affected due to the underlying disease and/or carotid and femoral arteries according to ultrasound examination | Evaluated in 12 months | |
| Atherogenicity changes in serum blood | Evaluated in 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolay Shakhpazyan, PhD; Dr. | Contact | +79168244496 | nshakhpazyan@gmail.com | |
| Alikhan Asoyan | Contact | +79772667620 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Atherosclerosis Research | Recruiting | Moscow | 121609 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34070542 | Background | 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. | |
| 34583224 | Background | 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. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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A randomized controlled trial with two parallel groups of participants
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A randomized, double-blinded, placebo-controlled trial
| Tertinat | Drug | Participants will take Tertinat capsules in addition to standard treatment for a year. |
|
| Changes in LDL sialic acid levels | Evaluated in 12 months |
| Changes in lipid profile indicators (total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol - calculated value) | Evaluated in 12 months |
| Changes in circulating immune complex cholesterol levels | Evaluated in 12 months |
| 34655047 | Background | 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. |
| 35585810 | Background | 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. |
| 35625910 | Background | 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. |
| 35897875 | Background | 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. |
| 36607090 | Background | 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. |
| 37513323 | Background | 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. |
| 37570643 | Background | 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. |
| 38088673 | Background | 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. |
| 38185888 | Background | 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. |
| 38204226 | Background | 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. |
| 38494931 | Background | 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. |
| 38808553 | Background | 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. |
| 38831578 | Background | Kashirskikh D, Chicherina N, Glanz V, Orekhov A, Sobenin I. Mouse Model of Low-density Lipoprotein Desialylation In Vivo. Curr Med Chem. 2026;33(8):1523-1537. doi: 10.2174/0109298673294745240528092506. |
| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |