AtherosclerosisPhase 4TEA-PARTYNCT05813171
The Effects of Allicor on Patients After Revascularization Treatment During a Year
A Phase 4 study testing Allicor in people with Atherosclerosis and Peripheral Arterial Disease, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atherosclerosis, Peripheral Arterial Disease
- What is being tested?
- Allicor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 20 Apr 2023to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Institute for Atherosclerosis Research
Moscow, 121609
Varvara A Orekhova, MD, +0079629325095, varvaraao@gmail.com
Alexander N Orekhov, PhD, DSc
About this study
Official title: The Effects of Dietary Supplementation Allicor on Patients With Multifocal Atherosclerosis After Peripheral Artery Revascularization Treatment During a Year
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.
Read the 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
- Being tested
- Allicor, Placebo
- Keywords
- atherosclerosis, inflammation, DNA, Mitochondrial
- Medical subject headings
- Atherosclerosis, Peripheral Arterial Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllicorDietary supplement
Also called 150 mg capsules of dried dried garlic powder
Participants will take Allicor capsules in addition to standard treatment for a year.
PlaceboDrug
Also called 150 mg inert capsules mimic capsules Allicor
Participants will take the placebo capsules in addition to standard treatment for a year.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Allicor | Active comparator | Dietary Supplement: Allicor 150 mg capsule by mouth two times a day during the year Receives: Dietary Supplement: Allicor |
| Placebo | Placebo comparator | Placebo capsule manufactured to mimic Allicor 150 mg capsule by mouth two times a day during the year Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Evaluated in 12 months from revascularization interventions
Frequency of indications for a second revascularization
Frequency of second revascularization events during the year.
Measured: 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)
According to angiography or ultrasonography examination
Measured: Evaluated in 6 and in 12 months from revascularization interventions
Variation of intima-media thickness of common carotid arteries
Variation of intima-media thickness of common carotid arteries measured with B-mode ultrasound of carotid arteria.
Measured: Evaluated in 6 and in 12 months from revascularization interventions
The maximal walking distance (MWD)
Measuring the maximal walking distance (MWD) with treadmill exercise testing
Measured: Evaluated in 6 and in 12 months from revascularization interventions
Change in the ankle-brachial index (ABI)
Determination of the ratio systolic blood pressure within the brachial arteries and systolic blood pressure within the ankle arteries.
Measured: 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
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.
Measured: Evaluated in 6 and in 12 months from revascularization 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.
Measured: Evaluated in 6 and in 12 months from revascularization interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion20 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two parallel groups of participants
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolay K Shakhpazyan, PhD; Dr., Principal investigator, "Russian research center of surgery named after academician B.V. Petrovsky"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813171
- Sponsor's protocol ID
- IAR-AL-MFA
- Acronym
- TEA-PARTY
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tunon J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. No abstract available.
PubMed 28851596Mahe G, Boge G, Bura-Riviere A, Chakfe N, Constans J, Goueffic Y, Lacroix P, Le Hello C, Pernod G, Perez-Martin A, Picquet J, Sprynger M; SFMV/SCVE group; SFMV/SCVE group. Disparities Between International Guidelines (AHA/ESC/ESVS/ESVM/SVS) Concerning Lower Extremity Arterial Disease: Consensus of the French Society of Vascular Medicine (SFMV) and the French Society for Vascular and Endovascular Surgery (SCVE). Ann Vasc Surg. 2021 Apr;72:1-56. doi: 10.1016/j.avsg.2020.11.011. Epub 2020 Dec 24.
PubMed 33359707Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C7-12. doi: 10.1016/j.jacc.2005.09.068.
PubMed 16631513Jaberi N, Soleimani A, Pashirzad M, Abdeahad H, Mohammadi F, Khoshakhlagh M, Khazaei M, Ferns GA, Avan A, Hassanian SM. Role of thrombin in the pathogenesis of atherosclerosis. J Cell Biochem. 2019 Apr;120(4):4757-4765. doi: 10.1002/jcb.27771. Epub 2018 Sep 30.
PubMed 30269382Bonati LH, Gregson J, Dobson J, McCabe DJH, Nederkoorn PJ, van der Worp HB, de Borst GJ, Richards T, Cleveland T, Muller MD, Wolff T, Engelter ST, Lyrer PA, Brown MM; International Carotid Stenting Study investigators. Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial. Lancet Neurol. 2018 Jul;17(7):587-596. doi: 10.1016/S1474-4422(18)30195-9. Epub 2018 Jun 1.
PubMed 29861139Paraskevas KI, Giannoukas AD, Mikhailidis DP. Statins and infrainguinal vascular bypass procedures. Curr Vasc Pharmacol. 2013 Jan;11(1):51-7.
PubMed 23391423Ceyhun G, Engin MC. The Monocyte/High Density Lipoprotein Cholesterol Ratio (MHR) as an Indicator of the Need for Amputation in Patients With Peripheral Artery Disease Developing Critical Limb Ischemia. Angiology. 2021 Mar;72(3):268-273. doi: 10.1177/0003319720965808. Epub 2020 Oct 14.
PubMed 33108889Ward NC, Watts GF, Eckel RH. Response by Ward et al to Letter Regarding Article, "Statin Toxicity: Mechanistic Insights and Clinical Implications". Circ Res. 2019 Jun 7;124(12):e121-e122. doi: 10.1161/CIRCRESAHA.119.315233. Epub 2019 Jun 6. No abstract available.
PubMed 31170055Bradley JM, Organ CL, Lefer DJ. Garlic-Derived Organic Polysulfides and Myocardial Protection. J Nutr. 2016 Feb;146(2):403S-409S. doi: 10.3945/jn.114.208066. Epub 2016 Jan 13.
PubMed 26764335Orekhov AN, Tertov VV. In vitro effect of garlic powder extract on lipid content in normal and atherosclerotic human aortic cells. Lipids. 1997 Oct;32(10):1055-60. doi: 10.1007/s11745-997-0136-7.
PubMed 9358431Orekhov AN, Grunwald J. Effects of garlic on atherosclerosis. Nutrition. 1997 Jul-Aug;13(7-8):656-63. doi: 10.1016/s0899-9007(97)83010-9.
PubMed 9263259Imaizumi VM, Laurindo LF, Manzan B, Guiguer EL, Oshiiwa M, Otoboni AMMB, Araujo AC, Tofano RJ, Barbalho SM. Garlic: A systematic review of the effects on cardiovascular diseases. Crit Rev Food Sci Nutr. 2023;63(24):6797-6819. doi: 10.1080/10408398.2022.2043821. Epub 2022 Feb 23.
PubMed 35193446Mollahosseini M, Hosseini-Marnani E, Panjeshahin A, Panbehkar-Jouybari M, Gheflati A, Mozaffari-Khosravi H. A systematic review of randomized controlled trials related to the effects of garlic supplementation on platelet aggregation. Phytother Res. 2022 Nov;36(11):4041-4050. doi: 10.1002/ptr.7556. Epub 2022 Oct 12.
PubMed 36222178Panyod S, Wu WK, Chen PC, Chong KV, Yang YT, Chuang HL, Chen CC, Chen RA, Liu PY, Chung CH, Huang HS, Lin AY, Shen TD, Yang KC, Huang TF, Hsu CC, Ho CT, Kao HL, Orekhov AN, Wu MS, Sheen LY. Atherosclerosis amelioration by allicin in raw garlic through gut microbiota and trimethylamine-N-oxide modulation. NPJ Biofilms Microbiomes. 2022 Jan 27;8(1):4. doi: 10.1038/s41522-022-00266-3.
PubMed 35087050Reinhart KM, Talati R, White CM, Coleman CI. The impact of garlic on lipid parameters: a systematic review and meta-analysis. Nutr Res Rev. 2009 Jun;22(1):39-48. doi: 10.1017/S0954422409350003.
PubMed 19555517
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Supplementation Allicor on Patients With Multifocal Atherosclerosis After Peripheral Artery Revascularization Treatment During a Year
- ClinicalTrials.gov ID
- NCT05813171
- Acronym / sponsor ID
- TEA-PARTY / IAR-AL-MFA
- Conditions
- Atherosclerosis, Peripheral Arterial Disease
- Keywords
- atherosclerosis, inflammation, DNA, Mitochondrial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two parallel groups of participants
| Arm | Type | Receives |
|---|---|---|
| Experimental: Allicor | Active comparator | Dietary Supplement: AllicorDietary Supplement: Allicor 150 mg capsule by mouth two times a day during the year |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule manufactured to mimic Allicor 150 mg capsule by mouth two times a day during the year |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllicorAlso: 150 mg capsules of dried dried garlic powderParticipants will take Allicor capsules in addition to standard treatment for a year. | Dietary supplement | Experimental: Allicor |
| PlaceboAlso: 150 mg inert capsules mimic capsules AllicorParticipants will take the placebo capsules in addition to standard treatment for a year. | Drug | Placebo |
Primary outcome
Frequency of fatal cardiovascular events
Time frame: Evaluated in 12 months from revascularization 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
Time frame: Evaluated in 12 months from revascularization interventions
Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure, hospitalization due to critical limb ischemia.
Frequency of indications for a second revascularization
Time frame: Evaluated in 12 months from revascularization interventions
Frequency of second revascularization events during the year.
6 secondary outcomes
Change in the degree of stenosis of the peripheral arteries (lower limbs arteries, common carotid arteries)
Time frame: Evaluated in 6 and in 12 months from revascularization interventions
Variation of intima-media thickness of common carotid arteries
Time frame: Evaluated in 6 and in 12 months from revascularization interventions
The maximal walking distance (MWD)
Time frame: Evaluated in 6 and in 12 months from revascularization interventions
Change in the ankle-brachial index (ABI)
Time frame: 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
Time frame: Evaluated in 6 and in 12 months from revascularization interventions
Changes in the percentage of heteroplasmy of the mitochondrial genome of blood leukocytes in variants associated with atherosclerosis
Time frame: Evaluated in 6 and in 12 months from revascularization interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 28851596Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tunon J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. No abstract available.
- Background: PubMed 33359707Mahe G, Boge G, Bura-Riviere A, Chakfe N, Constans J, Goueffic Y, Lacroix P, Le Hello C, Pernod G, Perez-Martin A, Picquet J, Sprynger M; SFMV/SCVE group; SFMV/SCVE group. Disparities Between International Guidelines (AHA/ESC/ESVS/ESVM/SVS) Concerning Lower Extremity Arterial Disease: Consensus of the French Society of Vascular Medicine (SFMV) and the French Society for Vascular and Endovascular Surgery (SCVE). Ann Vasc Surg. 2021 Apr;72:1-56. doi: 10.1016/j.avsg.2020.11.011. Epub 2020 Dec 24.
- Background: PubMed 16631513Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C7-12. doi: 10.1016/j.jacc.2005.09.068.
- Background: PubMed 30269382Jaberi N, Soleimani A, Pashirzad M, Abdeahad H, Mohammadi F, Khoshakhlagh M, Khazaei M, Ferns GA, Avan A, Hassanian SM. Role of thrombin in the pathogenesis of atherosclerosis. J Cell Biochem. 2019 Apr;120(4):4757-4765. doi: 10.1002/jcb.27771. Epub 2018 Sep 30.
- Background: PubMed 29861139Bonati LH, Gregson J, Dobson J, McCabe DJH, Nederkoorn PJ, van der Worp HB, de Borst GJ, Richards T, Cleveland T, Muller MD, Wolff T, Engelter ST, Lyrer PA, Brown MM; International Carotid Stenting Study investigators. Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial. Lancet Neurol. 2018 Jul;17(7):587-596. doi: 10.1016/S1474-4422(18)30195-9. Epub 2018 Jun 1.
- Background: PubMed 23391423Paraskevas KI, Giannoukas AD, Mikhailidis DP. Statins and infrainguinal vascular bypass procedures. Curr Vasc Pharmacol. 2013 Jan;11(1):51-7.
- Background: PubMed 33108889Ceyhun G, Engin MC. The Monocyte/High Density Lipoprotein Cholesterol Ratio (MHR) as an Indicator of the Need for Amputation in Patients With Peripheral Artery Disease Developing Critical Limb Ischemia. Angiology. 2021 Mar;72(3):268-273. doi: 10.1177/0003319720965808. Epub 2020 Oct 14.
- Background: PubMed 31170055Ward NC, Watts GF, Eckel RH. Response by Ward et al to Letter Regarding Article, "Statin Toxicity: Mechanistic Insights and Clinical Implications". Circ Res. 2019 Jun 7;124(12):e121-e122. doi: 10.1161/CIRCRESAHA.119.315233. Epub 2019 Jun 6. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolay K Shakhpazyan, PhD; Dr. principal investigator
"Russian research center of surgery named after academician B.V. Petrovsky"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allicor in people with Atherosclerosis and Peripheral Arterial Disease, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolay K Shakhpazyan, PhD; Dr. (+79168244496, nshakhpazyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of fatal cardiovascular events (time frame: Evaluated in 12 months from revascularization interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813171, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.