HypercholesterolemiaARMOLIPID-DTNCT07892092
Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins
An observational study of Hypercholesterolemia and Cardiovascular Risk, run by Aeterna Medical Solutions SL at 1 site in Spain.
Trial summary
The goal of this study, conducted entirely using computer simulations, is to evaluate the projected long-term cardiovascular impact of the new ArmoLIPID Cholesterol Plus formulation in adults with mild-to-moderate hypercholesterolemia and low-to-moderate cardiovascular risk. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Risk
- Type of treatment
- Pill or oral medicine
- How many people
- 100,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 14 Oct 2026
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Adult, Older adult
Study population: The study population consists of 100,000 synthetic digital twins representing adults aged 30 to 65 years with mild-to-moderate hypercholesterolemia, baseline LDL-C levels between 115 and 189 mg/dL, and low-to-moderate estimated cardiovascular risk according to SCORE2. The synthetic population excludes individuals with established atherosclerotic cardiovascular disease, diabetes mellitus, or high-to-very-high cardiovascular risk at baseline. Digital twins are generated and analyzed using the Aeterna Deep computational platform to simulate individual cardiovascular trajectories over a 20-year period. Three virtual management strategies are evaluated: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a hypothetical sustained 32% reduction in LDL-C. The study is conducted entirely in silico. No human participants are
Who may be able to join
- Synthetic digital twins representing adults aged 30 to 65 years.
- Baseline low-density lipoprotein cholesterol (LDL-C) levels between 115 and 189 mg/dL.
- Low-to-moderate estimated 10-year cardiovascular risk according to Systematic Coronary Risk Evaluation 2 (SCORE2).
- No history of established atherosclerotic cardiovascular disease (ASCVD).
- No diagnosis of diabetes mellitus at baseline.
- Availability of the simulated baseline characteristics required for cardiovascular risk estimation and longitudinal computational modeling.
Who cannot join
- Synthetic profiles representing individuals younger than 30 years or older than 65 years.
- Baseline LDL-C levels below 115 mg/dL or above 189 mg/dL.
- High or very high estimated cardiovascular risk according to SCORE2.
- History of established ASCVD, including previous myocardial infarction, ischemic stroke, or peripheral arterial disease.
- Diagnosis of diabetes mellitus at baseline.
- Synthetic profiles with missing or inconsistent baseline variables required for cardiovascular risk estimation or simulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Cardiovascular Impact of the New ArmoLIPID Cholesterol Plus Formulation: An In Silico Clinical Study Using 100,000 Digital Twins
The goal of this study, conducted entirely using computer simulations, is to evaluate the projected long-term cardiovascular impact of the new ArmoLIPID Cholesterol Plus formulation in adults with mild-to-moderate hypercholesterolemia and low-to-moderate cardiovascular risk.
The main questions this study aims to answer are:
Read more
- Does the addition of ArmoLIPID Cholesterol Plus to lifestyle management reduce the projected incidence of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke?
- How does sustained LDL cholesterol reduction influence cumulative cardiovascular risk over 5, 10, 15, and 20 years?
- Could the use of ArmoLIPID Cholesterol Plus delay the projected need for statin therapy?
Researchers will compare two simulated strategies: lifestyle management alone versus lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation.
No human participants will be recruited, treated, or followed in this study. Using the Aeterna Deep computational platform, researchers will generate a synthetic population of 100,000 digital twins whose characteristics reflect those of adults with mild-to-moderate hypercholesterolemia. The simulations will incorporate clinical evidence from previous studies and model individual cardiovascular trajectories over a 20-year period.
All cardiovascular outcomes will be computational projections rather than events observed in human participants.
- Conditions
- Hypercholesterolemia, Cardiovascular Risk
- Keywords
- Hypercholesterolemia, Cardiovascular Prevention, ArmoLIPID Cholesterol Plus, Nutraceuticals, Digital Twins, In Silico Clinical Trial, Major Adverse Cardiovascular Events (MACE), Low-density lipoprotein (LDL) cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Management (Reference Group) | Synthetic digital twins receiving simulated standard lifestyle management, including dietary recommendations, regular physical activity, and cardiovascular risk factor management, without ArmoLIPID Cholesterol Plus supplementation. This group serves as the reference comparator for estimating long-term cardiovascular outcomes over 5, 10, 15, and 20 years. | |
| Lifestyle Management + ArmoLIPID Cholesterol Plus | Synthetic digital twins receiving simulated standard lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. The simulation estimates the long-term effects of LDL cholesterol (LDL-C) reduction on cumulative cardiovascular exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years. | |
| Exploratory Scenario - Enhanced LDL-C Reduction (Two Tablets Daily) | Synthetic digital twins receiving simulated standard lifestyle management combined with two tablets daily of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. This exploratory scenario assumes a sustained 32% reduction in LDL cholesterol (LDL-C) from baseline and evaluates its potential long-term impact on cumulative LDL-C exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years. The assumed LDL-C reduction represents a hypothetical enhanced-response scenario and has not been clinically demonstrated for the two-tablet daily regimen. No human participants receive treatment in this simulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Projected Cumulative Incidence of First Major Adverse Cardiovascular Event (MACE)
Estimation of the projected cumulative incidence of a first major adverse cardiovascular event (MACE), defined as the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, using the Aeterna Deep digital twin simulation platform. The outcome will be assessed across three simulated strategies: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory scenario involving two tablets daily with an assumed 32% LDL cholesterol LDL-C reduction. Cumulative event probabilities, absolute risk differences, and model-derived hazard ratios will be estimated at 5, 10, 15, and 20 years. All events are computationally projected and are not observed clinical events in human participants.
Measured: From simulation baseline to 5, 10, 15, and 20 years
Secondary outcomes (7)
Projected Cumulative LDL Cholesterol Exposure Over 20 Years
Estimation of cumulative exposure to low-density lipoprotein cholesterol (LDL-C) over 5, 10, 15, and 20 years, calculated as the area under the simulated LDL-C concentration-time curve and expressed in mg/dL-years. The analysis will compare lifestyle management alone with lifestyle management plus one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL-C. Differences in cumulative LDL-C exposure between simulated strategies will be assessed to characterize the potential long-term impact of sustained cholesterol lowering. All LDL-C trajectories are computationally simulated and do not represent longitudinal measurements obtained from human participants.
Measured: From simulation baseline to 5, 10, 15, and 20 years
Projected Incidence of Statin Therapy Indication
Estimation of the projected proportion of synthetic digital twins meeting predefined clinical criteria for initiation of statin therapy over 5, 10, 15, and 20 years. The analysis will compare three simulated strategies: lifestyle management alone, lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Statin therapy indication will be determined using the cardiovascular risk and LDL-C thresholds specified in the simulation model. Differences between strategies will be assessed to estimate the potential impact of sustained LDL-C lowering on the future need for lipid-lowering pharmacotherapy. All outcomes are computational projections and do not represent treatment decisions made for human participants.
Measured: From simulation baseline to 5, 10, 15, and 20 years
Projected Time to First Statin Therapy Indication
Estimation of the simulated time from baseline to the first occurrence of predefined clinical criteria for statin therapy initiation, expressed in years. The analysis will compare lifestyle management alone, lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Time-to-event analyses will assess whether sustained LDL-C lowering may delay the projected indication for statin therapy. All outcomes are derived from computational simulations and do not represent actual prescribing decisions or clinical follow-up of human participants.
Measured: From simulation baseline up to 20 years
Projected Cardiovascular Outcomes According to Supplementation Adherence
Assessment of the association between simulated long-term adherence to ArmoLIPID Cholesterol Plus supplementation and the projected cumulative incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The analysis will evaluate adherence scenarios incorporated into the Aeterna Deep computational model and compare their projected cardiovascular outcomes over 5, 10, 15, and 20 years. All adherence patterns and cardiovascular events are computationally simulated and do not represent observed behavior or clinical outcomes in human participants.
Measured: From simulation baseline to 5, 10, 15, and 20 years
Projected Number Needed to Treat (NNT) to Prevent One Major Adverse Cardiovascular Event
Estimation of the model-derived number needed to treat (NNT) to prevent one first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The NNT will be calculated as the inverse of the absolute difference in projected cumulative MACE incidence between lifestyle management alone and each simulated ArmoLIPID Cholesterol Plus supplementation strategy at 5, 10, 15, and 20 years. The analysis will include the one-tablet daily strategy and the exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol. NNT estimates represent hypothetical benefits derived from computational simulations and should not be interpreted as clinically demonstrated treatment effects.
Measured: From simulation baseline to 5, 10, 15, and 20 years
Projected Major Adverse Cardiovascular Event-Free Survival Time
Estimation of the projected time free from a first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, over a 20-year simulation horizon. Restricted mean MACE-free survival time will be estimated from the simulated event-free survival curves and expressed in years. The analysis will compare lifestyle management alone with lifestyle management plus one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Between-strategy differences will be used to quantify the projected gain in MACE-free survival time. All estimates are derived from computational simulations and do not represent observed clinical outcomes in human participants.
Measured: From simulation baseline up to 20 years
Model-Derived Hazard Ratio for First Major Adverse Cardiovascular Event (MACE)
Estimation of model-derived hazard ratios (HRs) for the time to first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Hazard ratios will compare simulated lifestyle management alone with lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and, separately, an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Estimates will be accompanied by uncertainty intervals derived from the computational model. All hazard ratios represent simulated associations and should not be interpreted as treatment effects demonstrated in a clinical trial involving human participants.
Measured: From simulation baseline up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Sep 2026
- Primary completion3 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeterna Medical Solutions SL
- Sponsor type
- University, hospital or other
- Collaborators
- Cooper Consumer Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892092
- Sponsor's protocol ID
- AETERNA-ARMOLIPID-001
- Acronym
- ARMOLIPID-DT
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Individual data sharing
- No: This study is conducted entirely in silico using 100,000 synthetic digital twins generated and analyzed through the Aeterna Deep computational platform. No individual participant data from enrolled human subjects are collected or generated. The underlying synthetic datasets and simulation outputs are not planned for public sharing, as they form part of the proprietary computational framework of Aeterna Medical Solutions SL. Aggregated study findings will be disseminated through scientific publications and reports.
Publications
SCORE2-OP working group and ESC Cardiovascular risk collaboration. SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions. Eur Heart J. 2021 Jul 1;42(25):2455-2467. doi: 10.1093/eurheartj/ehab312.
PubMed 34120185Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
PubMed 21067804SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
PubMed 34120177Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
PubMed 28444290Fogacci F, Di Micoli V, Veronesi M, Cicero AFG. Comparative effect of a nutraceutical compound based on a flavonoid complex from bergamot on plasma lipids, glucose metabolism, and liver enzymes: a 3-arm, double-blind, placebo-controlled, randomized clinical trial. Arch Med Sci. 2022 Sep 9;19(5):1180-1185. doi: 10.5114/aoms/152791. eCollection 2023.
PubMed 37732027
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Cardiovascular Impact of the New ArmoLIPID Cholesterol Plus Formulation: An In Silico Clinical Study Using 100,000 Digital Twins
- ClinicalTrials.gov ID
- NCT07892092
- Acronym / sponsor ID
- ARMOLIPID-DT / AETERNA-ARMOLIPID-001
- Conditions
- Hypercholesterolemia, Cardiovascular Risk
- Keywords
- Hypercholesterolemia, Cardiovascular Prevention, ArmoLIPID Cholesterol Plus, Nutraceuticals, Digital Twins, In Silico Clinical Trial, Major Adverse Cardiovascular Events (MACE), Low-density lipoprotein (LDL) cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Aeterna Medical Solutions SLUniversity, hospital or other
- Collaborators
- Cooper Consumer Health
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 3 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 23 Oct 2026 (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.
The goal of this study, conducted entirely using computer simulations, is to evaluate the projected long-term cardiovascular impact of the new ArmoLIPID Cholesterol Plus formulation in adults with mild-to-moderate hypercholesterolemia and low-to-moderate cardiovascular risk.
The main questions this study aims to answer are:
- Does the addition of ArmoLIPID Cholesterol Plus to lifestyle management reduce the projected incidence of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke?
- How does sustained LDL cholesterol reduction influence cumulative cardiovascular risk over 5, 10, 15, and 20 years?
- Could the use of ArmoLIPID Cholesterol Plus delay the projected need for statin therapy?
Researchers will compare two simulated strategies: lifestyle management alone versus lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation.
No human participants will be recruited, treated, or followed in this study. Using the Aeterna Deep computational platform, researchers will generate a synthetic population of 100,000 digital twins whose characteristics reflect those of adults with mild-to-moderate hypercholesterolemia. The simulations will incorporate clinical evidence from previous studies and model individual cardiovascular trajectories over a 20-year period.
All cardiovascular outcomes will be computational projections rather than events observed in human participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Management (Reference Group) | – | –Synthetic digital twins receiving simulated standard lifestyle management, including dietary recommendations, regular physical activity, and cardiovascular risk factor management, without ArmoLIPID Cholesterol Plus supplementation. This group serves as the reference comparator for estimating long-term cardiovascular outcomes over 5, 10, 15, and 20 years. |
| Lifestyle Management + ArmoLIPID Cholesterol Plus | – | –Synthetic digital twins receiving simulated standard lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. The simulation estimates the long-term effects of LDL cholesterol (LDL-C) reduction on cumulative cardiovascular exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years. |
| Exploratory Scenario - Enhanced LDL-C Reduction (Two Tablets Daily) | – | –Synthetic digital twins receiving simulated standard lifestyle management combined with two tablets daily of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. This exploratory scenario assumes a sustained 32% reduction in LDL cholesterol (LDL-C) from baseline and evaluates its potential long-term impact on cumulative LDL-C exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years. The assumed LDL-C reduction represents a hypothetical enhanced-response scenario and has not been clinically demonstrated for the two-tablet daily regimen. No human participants receive treatment in this simulation. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 100,000 synthetic digital twins representing adults aged 30 to 65 years with mild-to-moderate hypercholesterolemia, baseline LDL-C levels between 115 and 189 mg/dL, and low-to-moderate estimated cardiovascular risk according to SCORE2. The synthetic population excludes individuals with established atherosclerotic cardiovascular disease, diabetes mellitus, or high-to-very-high cardiovascular risk at baseline. Digital twins are generated and analyzed using the Aeterna Deep computational platform to simulate individual cardiovascular trajectories over a 20-year period. Three virtual management strategies are evaluated: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a hypothetical sustained 32% reduction in LDL-C. The study is conducted entirely in silico. No human participants are
Key inclusion criteria (6 listed)
- Synthetic digital twins representing adults aged 30 to 65 years.
- Baseline low-density lipoprotein cholesterol (LDL-C) levels between 115 and 189 mg/dL.
- Low-to-moderate estimated 10-year cardiovascular risk according to Systematic Coronary Risk Evaluation 2 (SCORE2).
- No history of established atherosclerotic cardiovascular disease (ASCVD).
- No diagnosis of diabetes mellitus at baseline.
Key exclusion criteria (6 listed)
- Synthetic profiles representing individuals younger than 30 years or older than 65 years.
- Baseline LDL-C levels below 115 mg/dL or above 189 mg/dL.
- High or very high estimated cardiovascular risk according to SCORE2.
- History of established ASCVD, including previous myocardial infarction, ischemic stroke, or peripheral arterial disease.
- Diagnosis of diabetes mellitus at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Projected Cumulative Incidence of First Major Adverse Cardiovascular Event (MACE)
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Estimation of the projected cumulative incidence of a first major adverse cardiovascular event (MACE), defined as the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, using the Aeterna Deep digital twin simulation platform. The outcome will be assessed across three simulated strategies: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory scenario involving two tablets daily with an assumed 32% LDL cholesterol LDL-C reduction. Cumulative event probabilities, absolute risk differences, and model-derived hazard ratios will be estimated at 5, 10, 15, and 20 years. All events are computationally projected and are not observed clinical events in human participants.
7 secondary outcomes
Projected Cumulative LDL Cholesterol Exposure Over 20 Years
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Incidence of Statin Therapy Indication
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Time to First Statin Therapy Indication
Time frame: From simulation baseline up to 20 years
Projected Cardiovascular Outcomes According to Supplementation Adherence
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Number Needed to Treat (NNT) to Prevent One Major Adverse Cardiovascular Event
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Major Adverse Cardiovascular Event-Free Survival Time
Time frame: From simulation baseline up to 20 years
Model-Derived Hazard Ratio for First Major Adverse Cardiovascular Event (MACE)
Time frame: From simulation baseline up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 34120185SCORE2-OP working group and ESC Cardiovascular risk collaboration. SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions. Eur Heart J. 2021 Jul 1;42(25):2455-2467. doi: 10.1093/eurheartj/ehab312.
- Background: PubMed 21067804Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
- Background: PubMed 34120177SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
- Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Background: PubMed 28444290Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
- Background: PubMed 37732027Fogacci F, Di Micoli V, Veronesi M, Cicero AFG. Comparative effect of a nutraceutical compound based on a flavonoid complex from bergamot on plasma lipids, glucose metabolism, and liver enzymes: a 3-arm, double-blind, placebo-controlled, randomized clinical trial. Arch Med Sci. 2022 Sep 9;19(5):1180-1185. doi: 10.5114/aoms/152791. eCollection 2023.
- Individual participant dataSharing planned: No. This study is conducted entirely in silico using 100,000 synthetic digital twins generated and analyzed through the Aeterna Deep computational platform. No individual participant data from enrolled human subjects are collected or generated. The underlying synthetic datasets and simulation outputs are not planned for public sharing, as they form part of the proprietary computational framework of Aeterna Medical Solutions SL. Aggregated study findings will be disseminated through scientific publications and reports.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Cardiovascular Risk, run by Aeterna Medical Solutions SL at 1 site in Spain.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Oct 2026. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Projected Cumulative Incidence of First Major Adverse Cardiovascular Event (MACE) (time frame: From simulation baseline to 5, 10, 15, and 20 years). 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 NCT07892092, which also lists 6 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 28 Oct 2026.