Table of Contents
- Trial overview
- Cross-over study in coronary risk control
- Phase 3 study in acute coronary syndrome
- Main endpoints and what they mean
- Who the trials are for
- How the studies are designed
Trial overview
The available trials investigating Atorvastatin Calcium Trihydrate are focused on cardiovascular care, especially in people with coronary risk factors and acute coronary syndrome.[1][2] The studies are authorised and include one low-intervention trial and one Phase 3 randomized study.[1][2]
Cross-over study in coronary risk control
NCT05030818 is a cross-over analysis called the POLICROSS trial, and it studies the degree of control of coronary risk factors and platelet aggregation.[1] A cross-over study means the same patient receives different treatment periods, so results can be compared within the same person.[1]
This study compares 3 months of treatment with the Trinomia polypill against 3 months with the components given separately.[1] The brief summary says the trial will analyze systolic blood pressure and LDL cholesterol in the same patient during these two periods.[1]
The trial is listed as Low Intervention and has an enrollment of 88 participants.[1]
Phase 3 study in acute coronary syndrome
The second study, 2025-524751-32-00, is a randomized trial in patients with acute coronary syndrome.[2] It evaluates the added effect of prescribing the cardiovascular polypill at hospital discharge together with a nurse-led education program.[2]
This trial is Phase 3 and includes 216 participants.[2] The study uses a blinded nursing team to assess adherence one year after admission, which helps reduce bias in the results.[2]
The adherence assessment uses four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up.[2] Patients are considered adherent only if they meet the criteria in all four methods.[2]
Main endpoints and what they mean
The main endpoint in the first study is systolic blood pressure and LDL cholesterol.[1] Systolic blood pressure is the top number in a blood pressure reading, and LDL cholesterol is often called bad cholesterol because high levels can raise heart risk.
The main endpoint in the second study is therapeutic adherence one year after admission.[2] Therapeutic adherence means how well patients follow the treatment plan in real life, including taking medicine and keeping follow-up visits.
The first study also focuses on the control of coronary risk factors and platelet aggregation, while the second study focuses on whether a polypill plus education improves treatment follow-through after a heart event.[1][2]
Who the trials are for
The first study is aimed at people with coronary risk factors, meaning health problems that can raise the chance of heart disease.[1] The second study is aimed at patients with acute coronary syndrome after admission to the hospital.[2]
These trials are not broad population studies; they focus on patients with specific cardiovascular conditions where control of cholesterol, blood pressure, and treatment adherence matters most.[1][2]
How the studies are designed
The POLICROSS trial uses a cross-over design, which lets each participant serve as their own comparison.[1] This can help researchers see whether changes are linked to the treatment period rather than to differences between patients.
The Phase 3 study is randomized, which means participants are assigned by chance to study groups.[2] Random assignment helps make the comparison between groups more fair.
Both studies involve oral treatment options listed in the source data, including Trinomia, Cardyl, Acovil, and Adiro, but the trial records provided here focus on outcomes rather than detailed drug testing explanations.[1][2]
