Cardiovascular diseases (CVD) are the leading cause of death worldwide, and their incidence is increasing sharply in developing countries. Two insufficiently addressed factors contribute to increased morbidity and mortality, threatening the effectiveness of any health system: poor patient adherence to treatment, and limited access to medication in resource-poor countries and regions. To address these issues, FOCUS aims to test the Fixed-Dose-Combination (FDC) concept for CVD prevention and treatment in populations with diverse socio-economic characteristics. The FOCUS FDC pill developed by the consortium is a single-day pill containing three active components of well-demonstrated efficacy. It can be produced and administrated at a much lower cost than conventional multi-pill equivalents and is thus especially suitable for widespread use in resource-poor countries. The FDC pill will be tested in two complementary controlled clinical studies: a descriptive non-interventional study followed by an interventional randomized trial. The studies will analyze data collected at 40 clinical sites in Europe and 40 sites in three middle-income developing countries. FOCUS is an international collaboration between research institutes, clinicians, pharma industry, SMEs and scientific organisations. It aims to establish a proof of concept of FDC efficacy for secondary CVD prevention, and a better understanding of socio-economic factors that influence access and adherence to CVD treatment. Based on the project results FOCUS will publish recommendations for the use of this medication to improve patient adherence and access to CVD prevention medication in developing countries and beyond. A successful project will directly contribute to improved use of clinical research findings for treatment of CVD diseases and to creating equitable access to a more efficient CVD prevention medication for patients in developed and resource-poor countries.