The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

Phase 4

Recruiting

• Conditions: Myocardial Ischemia; Coronary Artery Bypass Grafting; Coronary Arteriosclerosis; Percutaneous Coronary Revascularization
• Interventions: Dietary Supplement: Allicor; Drug: Placebo

• Registration Number: NCT05803759
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Study First Posted: 2023-04-07
• Study Start: 2023-04-10
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age >40 and <75 years
2. Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
3. 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.
4. The possibility of monitoring the patient for 12 months after revascularization, including phone contacts and visits to the clinic after 6 and 12 months.
5. 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.

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Exclusion Criteria

1. Repeated revascularization surgery.
2. 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).
3. 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)
4. High degree of disability of the patient (4 or higher points on the modified Rankin scale).
5. History of systemic autoimmune diseases.
6. Significant weight loss (> 10% of body weight in the previous year) of unknown etiology.
7. Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).
8. Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.
9. Patients with malignant tumors, including the postoperative period with chemotherapy and / or radiation therapy.
10. Carriers of HIV or viral hepatitis
11. Pregnancy or breast feeding
12. Refusal to participate in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allicor	Allicor	Dietary Supplement: Allicor 150 mg capsule by mouth two times a day
Placebo	Placebo	Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day

Primary Outcome Measures

Name	Time	Method
Frequency of fatal cardiovascular events	Evaluated in 12 months from revascularisation interventions	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.
Frequency of clinically significant cardiovascular events	Evaluated in 12 months from revascularisation interventions	Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure
Frequency of indications for a second revascularization	Evaluated in 12 months from revascularisation interventions

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Change in the degree of stenosis of the coronary arteries	Evaluated in 6 and in 12 months from revascularisation interventions	According to angiography examination
B-mode ultrasound of carotid arteries	Evaluated in 6 and in 12 months from revascularisation interventions	Variation of intima-media thickness of common carotid arteries

Trial Locations

Locations (1)

Institute for Atherosclerosis Research; 🇷🇺 Moscow, Russian Federation