The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Dietary Supplementation Allicor on the Effectiveness of Treatment of Patients After Coronary Arteria Revascularization

Conditions
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Myocardial Ischemia, Coronary Artery Bypass Grafting, Coronary Arteriosclerosis, Percutaneous Coronary Revascularization

Intervention / Treatment
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* Dietary Supplement: Allicor
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allicor<br>Dietary Supplement: Allicor 150 mg capsule by mouth two times a day | Dietary Supplement: Allicor<br>* Each capsule contains 150 mg dried garlic powder<br>* Other names: 150 mg capsules of dried dried garlic powder;|
| Placebo Comparator: Placebo<br>Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day | Drug: Placebo<br>* Capsules manufactured to mimic Allicor 150 mg capsules<br>* Other names: Allicor immitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the degree of stenosis of the coronary arteries | According to angiography examination | Evaluated in 6 and in 12 months from revascularisation interventions | 
| B-mode ultrasound of carotid arteries | Variation of intima-media thickness of common 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 | Cytokine level measurement by ELISA (TNF-a; IL-1b; IL-6; IL-8; IL-10; CCL2) after the first and second LPS stimulation of monocytes. | 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 | Includes variants m.12315G>A, m.13513G>A, m.14459G>A, m.14846G>A, m.15059G>A, m.1555A>G, m.3256C>T, m.3336T>C, m.5178C>A, m.652delG measured with quantitative PCR. | Evaluated in 6 and in 12 months from revascularisation interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Allicin, Mitochondrial Genome