Clinical Research Directory

Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins

Sponsor: Aeterna Medical Solutions SL

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. 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.

Official title: Long-Term Cardiovascular Impact of the New ArmoLIPID Cholesterol Plus Formulation: An In Silico Clinical Study Using 100,000 Digital Twins

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