Myocardial IschemiaPhase 4TEA-CARTNCT05803759
The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment
A Phase 4 study testing Allicor in people with Myocardial Ischemia and Coronary Artery Bypass Grafting, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Myocardial Ischemia, Coronary Artery Bypass Grafting, Coronary Arteriosclerosis
- 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
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 10 Apr 2023to 31 Mar 2025
- Phase
- Phase 4
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
- Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
- 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.
- 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.
- 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.
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- 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, 1 recruiting
- Recruiting
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 the Effectiveness of Treatment of Patients After Coronary Arteria Revascularization
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.
- Conditions
- Myocardial Ischemia, Coronary Artery Bypass Grafting, Coronary Arteriosclerosis, Percutaneous Coronary Revascularization
- Being tested
- Allicor, Placebo
- Keywords
- Inflammation, Allicin, Mitochondrial Genome
- Medical subject headings
- Myocardial Ischemia, Coronary Artery 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
Each capsule contains 150 mg dried garlic powder
PlaceboDrug
Also called Allicor immitation
Capsules manufactured to mimic Allicor 150 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Allicor | Active comparator | Dietary Supplement: Allicor 150 mg capsule by mouth two times a day Receives: Dietary Supplement: Allicor |
| Placebo | Placebo comparator | Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day 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 revascularisation 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
Measured: Evaluated in 12 months from revascularisation interventions
Frequency of indications for a second revascularization
Measured: Evaluated in 12 months from revascularisation interventions
Secondary outcomes (4)
Change in the degree of stenosis of the coronary arteries
According to angiography examination
Measured: Evaluated in 6 and in 12 months from revascularisation interventions
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Measured: Evaluated in 6 and in 12 months from revascularisation 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 revascularisation 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 revascularisation interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start10 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803759
- Sponsor's protocol ID
- IAR-AL-CAR
- Acronym
- TEA-CART
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falk 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 16631513Bradley 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 19555517Orekhov AN, Sobenin IA, Korneev NV, Kirichenko TV, Myasoedova VA, Melnichenko AA, Balcells M, Edelman ER, Bobryshev YV. Anti-atherosclerotic therapy based on botanicals. Recent Pat Cardiovasc Drug Discov. 2013 Apr;8(1):56-66. doi: 10.2174/18722083113079990008.
PubMed 23176379Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
PubMed 20958974Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5.
PubMed 32349742Lindstedt S, Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Sheikh R. Successful improved peripheral tissue perfusion was seen in patients with atherosclerosis after 12 months of treatment with aged garlic extract. Int Wound J. 2021 Oct;18(5):681-691. doi: 10.1111/iwj.13570. Epub 2021 Feb 16.
PubMed 33590955Hamal S, Cherukuri L, Birudaraju D, Matsumoto S, Kinninger A, Chaganti BT, Flores F, Shaikh K, Roy SK, Budoff MJ. Short-term impact of aged garlic extract on endothelial function in diabetes: A randomized, double-blind, placebo-controlled trial. Exp Ther Med. 2020 Feb;19(2):1485-1489. doi: 10.3892/etm.2019.8377. Epub 2019 Dec 27.
PubMed 32010327Gao X, Xue Z, Ma Q, Guo Q, Xing L, Santhanam RK, Zhang M, Chen H. Antioxidant and antihypertensive effects of garlic protein and its hydrolysates and the related mechanism. J Food Biochem. 2020 Feb;44(2):e13126. doi: 10.1111/jfbc.13126. Epub 2019 Dec 26.
PubMed 31877235Ried K. Garlic lowers blood pressure in hypertensive subjects, improves arterial stiffness and gut microbiota: A review and meta-analysis. Exp Ther Med. 2020 Feb;19(2):1472-1478. doi: 10.3892/etm.2019.8374. Epub 2019 Dec 27.
PubMed 32010325