The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

NCT05803759 | Unknown Phase 4

• 1 other identifier: IAR-AL-CAR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary revascularization interventions such as coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are the standard of surgical treatment of patients with myocardial ischemia. However, up to 30% of patients experience complications of varying degrees within 12 months after the revascularization, or need for second intervention. Thus, it is necessary to search for additional approaches to the postoperative treatment of patients in order to improve the long-term results of revascularization treatment. Substances of natural origin with an anti-atherosclerotic effect have a good potential. These substances, as dietary supplements, can be taken by patients for a long time in conjunction with other prescribed medicines and treatments. Another valuable direction of investigations is the search for predictors of long-term cardiovascular complications after revascularization, which can be markers of inflammation and heteroplasmy levels of the patient's mitochondrial genome. The purpose of this study is to determine whether the intake of dietary supplement Allicor at a daily dose of 300 mg affects the frequency of long-term postoperative cardiovascular complications and re-intervention in patients after revascularization operations on the coronary arteries. The second goal is assessing the relationship between the grade monocytes inflammatory response and the level of heteroplasmy of the mitochondrial genome of blood leukocytes with the frequency of cardiovascular complications and re-interventions.

Conditions

Myocardial Ischemia; Coronary Artery Bypass Grafting; Coronary Arteriosclerosis; Percutaneous Coronary Revascularization

Keywords

Inflammation; Allicin; Mitochondrial Genome

Outcome Measures

Primary Outcomes (3)

• 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 revascularisation 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

  Evaluated in 12 months from revascularisation interventions

• Frequency of indications for a second revascularization

  Evaluated in 12 months from revascularisation interventions

Secondary Outcomes (4)

• Change in the degree of stenosis of the coronary arteries

  Evaluated in 6 and in 12 months from revascularisation interventions

• B-mode ultrasound of carotid arteries

  Evaluated in 6 and in 12 months from revascularisation interventions

• Change in the level of cytokine response of monocytes after double stimulation with lipopolysaccharide in in vitro cell culture

  Evaluated in 6 and in 12 months from revascularisation interventions

• Changes in the percentage of heteroplasmy of the mitochondrial genome of blood leukocytes in variants associated with atherosclerosis

  Evaluated in 6 and in 12 months from revascularisation interventions

Study Arms (2)

Allicor

ACTIVE COMPARATOR

Dietary Supplement: Allicor 150 mg capsule by mouth two times a day

Dietary Supplement: Allicor

Placebo

PLACEBO COMPARATOR

Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day

Drug: Placebo

Interventions

Allicor DIETARY_SUPPLEMENT

Each capsule contains 150 mg dried garlic powder

Also known as: 150 mg capsules of dried dried garlic powder

Allicor

Placebo DRUG

Capsules manufactured to mimic Allicor 150 mg capsules

Also known as: Allicor immitation

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 and \<75 years
• Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
• Patients passed a complex of instrumental and laboratory examinations before revascularization, including ECG, echocardiography, visualization of coronary vessels by X-ray contrast angiography, or CT, screening for atherosclerotic lesions of large arteries, including common carotid arteries, abdominal segment of the aorta, arteries of the lower extremities, biochemical analysis of blood included assessment of cholesterol, triglycerides, low density lipoproteins, high density lipoproteins and glucose levels.
• The possibility of monitoring the patient for 12 months after revascularization, including phone contacts and visits to the clinic after 6 and 12 months.
• Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Repeated revascularization surgery.
• 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)
• High degree of disability of the patient (4 or higher points on the modified Rankin scale).
• History of systemic autoimmune diseases.
• 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.
• Patients with malignant tumors, including the postoperative period with chemotherapy and / or radiation therapy.
• Carriers of HIV or viral hepatitis
• Pregnancy or breast feeding
• Refusal to participate in the study.

Sponsors & Collaborators

• Institute for Atherosclerosis Research, Russia: lead

Study Sites (1)

Institute for Atherosclerosis Research

Moscow, 121609, Russia

RECRUITING

Related Publications (16)

• Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C7-12. doi: 10.1016/j.jacc.2005.09.068.

  PMID: 16631513 BACKGROUND

• Bradley JM, Organ CL, Lefer DJ. Garlic-Derived Organic Polysulfides and Myocardial Protection. J Nutr. 2016 Feb;146(2):403S-409S. doi: 10.3945/jn.114.208066. Epub 2016 Jan 13.

  PMID: 26764335 BACKGROUND

• Orekhov AN, Tertov VV. In vitro effect of garlic powder extract on lipid content in normal and atherosclerotic human aortic cells. Lipids. 1997 Oct;32(10):1055-60. doi: 10.1007/s11745-997-0136-7.

  PMID: 9358431 BACKGROUND

• Orekhov AN, Grunwald J. Effects of garlic on atherosclerosis. Nutrition. 1997 Jul-Aug;13(7-8):656-63. doi: 10.1016/s0899-9007(97)83010-9.

  PMID: 9263259 BACKGROUND

• Imaizumi VM, Laurindo LF, Manzan B, Guiguer EL, Oshiiwa M, Otoboni AMMB, Araujo AC, Tofano RJ, Barbalho SM. Garlic: A systematic review of the effects on cardiovascular diseases. Crit Rev Food Sci Nutr. 2023;63(24):6797-6819. doi: 10.1080/10408398.2022.2043821. Epub 2022 Feb 23.

  PMID: 35193446 BACKGROUND

• Mollahosseini M, Hosseini-Marnani E, Panjeshahin A, Panbehkar-Jouybari M, Gheflati A, Mozaffari-Khosravi H. A systematic review of randomized controlled trials related to the effects of garlic supplementation on platelet aggregation. Phytother Res. 2022 Nov;36(11):4041-4050. doi: 10.1002/ptr.7556. Epub 2022 Oct 12.

  PMID: 36222178 BACKGROUND

• Panyod S, Wu WK, Chen PC, Chong KV, Yang YT, Chuang HL, Chen CC, Chen RA, Liu PY, Chung CH, Huang HS, Lin AY, Shen TD, Yang KC, Huang TF, Hsu CC, Ho CT, Kao HL, Orekhov AN, Wu MS, Sheen LY. Atherosclerosis amelioration by allicin in raw garlic through gut microbiota and trimethylamine-N-oxide modulation. NPJ Biofilms Microbiomes. 2022 Jan 27;8(1):4. doi: 10.1038/s41522-022-00266-3.

  PMID: 35087050 BACKGROUND

• Reinhart KM, Talati R, White CM, Coleman CI. The impact of garlic on lipid parameters: a systematic review and meta-analysis. Nutr Res Rev. 2009 Jun;22(1):39-48. doi: 10.1017/S0954422409350003.

  PMID: 19555517 BACKGROUND

• Orekhov AN, Sobenin IA, Korneev NV, Kirichenko TV, Myasoedova VA, Melnichenko AA, Balcells M, Edelman ER, Bobryshev YV. Anti-atherosclerotic therapy based on botanicals. Recent Pat Cardiovasc Drug Discov. 2013 Apr;8(1):56-66. doi: 10.2174/18722083113079990008.

  PMID: 23176379 BACKGROUND

• Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.

  PMID: 20958974 BACKGROUND

• Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5.

  PMID: 32349742 BACKGROUND

• Lindstedt S, Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Sheikh R. Successful improved peripheral tissue perfusion was seen in patients with atherosclerosis after 12 months of treatment with aged garlic extract. Int Wound J. 2021 Oct;18(5):681-691. doi: 10.1111/iwj.13570. Epub 2021 Feb 16.

  PMID: 33590955 BACKGROUND

• Hamal S, Cherukuri L, Birudaraju D, Matsumoto S, Kinninger A, Chaganti BT, Flores F, Shaikh K, Roy SK, Budoff MJ. Short-term impact of aged garlic extract on endothelial function in diabetes: A randomized, double-blind, placebo-controlled trial. Exp Ther Med. 2020 Feb;19(2):1485-1489. doi: 10.3892/etm.2019.8377. Epub 2019 Dec 27.

  PMID: 32010327 BACKGROUND

• Gao X, Xue Z, Ma Q, Guo Q, Xing L, Santhanam RK, Zhang M, Chen H. Antioxidant and antihypertensive effects of garlic protein and its hydrolysates and the related mechanism. J Food Biochem. 2020 Feb;44(2):e13126. doi: 10.1111/jfbc.13126. Epub 2019 Dec 26.

  PMID: 31877235 BACKGROUND

• Ried K. Garlic lowers blood pressure in hypertensive subjects, improves arterial stiffness and gut microbiota: A review and meta-analysis. Exp Ther Med. 2020 Feb;19(2):1472-1478. doi: 10.3892/etm.2019.8374. Epub 2019 Dec 27.

  PMID: 32010325 BACKGROUND

• Piragine E, Citi V, Lawson K, Calderone V, Martelli A. Potential Effects of Natural H2S-Donors in Hypertension Management. Biomolecules. 2022 Apr 14;12(4):581. doi: 10.3390/biom12040581.

  PMID: 35454169 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nikolay Shakhpazyan, PhD; Dr.

CONTACT

+79168244496; nshakhpazyan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: April 10, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-03

Locations

RU (1)