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

NCT05813171 | Unknown Phase 4

• 1 other identifier: IAR-AL-MFA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis; Peripheral Arterial Disease

Keywords

atherosclerosis; inflammation; DNA, Mitochondrial

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 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

• Frequency of indications for a second revascularization

  Frequency of second revascularization events during the year.

  Evaluated in 12 months from revascularization interventions

Secondary Outcomes (6)

• Change in the degree of stenosis of the peripheral arteries (lower limbs arteries, common carotid arteries)

  Evaluated in 6 and in 12 months from revascularization interventions

• Variation of intima-media thickness of common carotid arteries

  Evaluated in 6 and in 12 months from revascularization interventions

• The maximal walking distance (MWD)

  Evaluated in 6 and in 12 months from revascularization interventions

• Change in the ankle-brachial index (ABI)

  Evaluated in 6 and in 12 months from revascularization 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 revascularization interventions

Study Arms (2)

Experimental: Allicor

ACTIVE COMPARATOR

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

Dietary Supplement: Allicor

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Allicor DIETARY_SUPPLEMENT

Participants will take Allicor capsules in addition to standard treatment for a year.

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

Experimental: Allicor

Placebo DRUG

Participants will take the placebo capsules in addition to standard treatment for a year.

Also known as: 150 mg inert capsules mimic capsules Allicor

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
• A revascularization (including stenting, endarterectomy, artery prosthetic or bypass grafting) is indicated for the patient because of chronic atherosclerotic obliteration of the arteries of the lower extremities and/or common carotid arteries.
• Patients passed a complex of instrumental and laboratory examinations before revascularization, including X-ray contrast angiography or ultrasound examination of common carotid arteries and arteries of the lower extremities, the ankle-brachial index (ABI) assessment, 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.
• Trophic ulcers of the lower extremities.
• 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

Location

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MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease; Inflammation

Interventions

tebufenozide

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolay K Shakhpazyan, PhD; Dr.

  "Russian research center of surgery named after academician B.V. Petrovsky"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolay K 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
• Masking Details: A randomized, double-blinded, placebo-controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial with two parallel groups of participants

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 14, 2023
• Study Start: April 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: May 31, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

RU (1)