NCT05813171

The Effects of Allicor on Patients After Revascularization Treatment During a Year

The Effects of Dietary Supplementation Allicor on Patients With Multifocal Atherosclerosis After Peripheral Artery Revascularization Treatment During a Year

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Institute for Atherosclerosis Research, Russia · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A significant challenge in medical care is atherosclerotic occlusion of peripheral arteries, such as lower extremities and brachiocephalic arteries, which can eventually lead to loss of limbs or fatal ischemic strokes. Revascularizing surgical interventions can restore the lumen of the arteries and provide an effective way to treat such patients. However, up to a third of patients need re-intervention or experience cardiovascular complications within a year after surgery. The purpose of this study is to evaluate the effect of adding the natural dietary supplement Allicor to conventional treatment on the incidence of cardiovascular complications and treatment effectiveness 12 months after revascularization. Another valuable area of investigation is the search for predictors of long-term cardiovascular complications after revascularization, which could be markers of inflammation and heteroplasmy levels in the patient's mitochondrial genome.

Detailed description

Recently, atherosclerosis of large arteries has become a common problem affecting the quality of life and life expectancy of the population. In addition to atherosclerosis of coronary arteries leading to myocardial ischemia, another significant issue is atherosclerosis of the lower limb and brachiocephalic arteries. Typically, arteries are affected in multiple areas, resulting in multifocal atherosclerosis of several arterial basins. Consequently, 14 to 19% of patients suffering from damage to the arteries of the lower extremities have significant stenosis of the common carotid arteries. Clinical guidelines from the European Society of Cardiology (ESC) and the European Society for Vascular Surgery (ESVS) emphasize the need to examine other arteries in patients with atherosclerosis of the arteries of the lower extremities. Clinical screening for carotid and subclavian artery stenosis is also recommended. The surgical method for treating arterial occlusive lesions includes revascularization interventions to restore blood flow, thus eliminating tissue ischemia and preventing fatal and disabling consequences. In addition to surgical treatment, medications that lower blood cholesterol and reduce blood thrombogenesis are used. An important predictor of disease and treatment efficiency is the level of systemic inflammatory markers, such as protein-C. An anti-inflammatory approach is not used for treating patients with multifocal atherosclerosis. However, investigating new markers of inflammation may be promising for the development of new diagnostics. Insofar as up to a third of patients face the need for re-intervention or suffer cardiovascular complications within a year after revascularization surgery, the search for new approaches to treat multifocal arterial atherosclerosis is necessary. Long-term use of drugs of natural origin with anti-inflammatory and anti-atherosclerotic effects may be promising. Dietary Supplementation Allicor consists of dried garlic. There is a trial study (ClinicalTrials.gov Identifier: NCT01734707) that determined the ability of Allicor to have a beneficial effect on patients with atherosclerosis, and there are also data on the beneficial effect of Allicor on the condition of patients with coronary heart disease. Another randomized, double-blind, placebo-controlled trial of a dietary supplement made of garlic (ClinicalTrials.gov Identifier: NCT03860350) found benefits for patients with coronary artery atherosclerosis. Thus, there is reason to believe that Allicor will improve treatment outcomes in patients with multifocal atherosclerosis. The aim of this study is to investigate how the addition of Allicor to the standard treatment affects the incidence of serious cardiovascular events during a year after revascularization intervention. Also to be assessed is the need for repeated operations, as well as an evaluation of arterial flow and arterial wall. The study will also assess promising markers related to atherosclerosis and inflammation - an in vitro monocyte cytokine release test, and heteroplasmy levels of the patient's mitochondrial genome variants associated with atherosclerosis.

Conditions

• Atherosclerosis
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Allicor	Participants will take Allicor capsules in addition to standard treatment for a year.
DRUG	Placebo	Participants will take the placebo capsules in addition to standard treatment for a year.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-04-20
• Completion: 2024-05-31
• First posted: 2023-04-14
• Last updated: 2023-04-19

Locations

1 site across 1 country: Russia