The Effects of Allicor on Patients After Revascularization Treatment During a Year
NCT05813171 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2023-04-19
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
Interventions
- DIETARY_SUPPLEMENT
-
Allicor
Participants will take Allicor capsules in addition to standard treatment for a year.
- DRUG
-
Participants will take the placebo capsules in addition to standard treatment for a year.
Sponsors & Collaborators
-
Institute for Atherosclerosis Research, Russia
lead OTHER
Principal Investigators
-
Nikolay K Shakhpazyan, PhD; Dr. · "Russian research center of surgery named after academician B.V. Petrovsky"
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-20
- Primary Completion
- 2024-04-20
- Completion
- 2024-05-31
Countries
- Russia
Study Locations
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