Trial · NCT07892092
Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins
NCT07892092, Completed, Aeterna Medical Solutions SL
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins. Trials, record NCT07892092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892092
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins
- NCT number
- NCT07892092
- Status
- Completed
- Enrollment
- 100,000 participants, actual
- Lead sponsor
- Aeterna Medical Solutions SL
- Conditions
- Hypercholesterolemia, Cardiovascular Risk
- First posted
- 2026-10-23
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Projected Cumulative Incidence of First Major Adverse Cardiovascular Event (MACE) | 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. |
| Secondary | Projected Cumulative LDL Cholesterol Exposure Over 20 Years | From simulation baseline to 5, 10, 15, and 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. |
| Secondary | Projected Incidence of Statin Therapy Indication | From simulation baseline to 5, 10, 15, and 20 years | 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. |
| Secondary | Projected Time to First Statin Therapy Indication | From simulation baseline up to 20 years | 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. |
| Secondary | Projected Cardiovascular Outcomes According to Supplementation Adherence | From simulation baseline to 5, 10, 15, and 20 years | 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. |
| Secondary | Projected Number Needed to Treat (NNT) to Prevent One Major Adverse Cardiovascular Event | From simulation baseline to 5, 10, 15, and 20 years | 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. |
| Secondary | Projected Major Adverse Cardiovascular Event-Free Survival Time | From simulation baseline up to 20 years | 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. |
| Secondary | Model-Derived Hazard Ratio for First Major Adverse Cardiovascular Event (MACE) | From simulation baseline up to 20 years | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07892092
GET https://conductscience.org/api/trials/v1/NCT07892092/registered