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Secondary prEvention of CardiovascUlaR disease in the Elderly trial

Project description

DEENESFRITPL

Improving cardiovascular health in the elderly with polypill intervention

Treatment of cardiovascular diseases (CVD) often requires a combination of drugs, which is associated with suboptimal adherence. This reduces the effectiveness and clinical benefit, worsening disease symptoms and increasing mortality. The EU-funded SECURE project aims to evaluate a fixed dose combination polypill for secondary cardiovascular prevention in individuals aged 65 and above. Through a clinical trial, it will evaluate the potential benefits of the polypill as a cost-effective and globally accessible treatment strategy, comparing it to standard therapy. Secondary endpoints include evaluating adherence, risk factor control, pharmacoeconomic impact, regional differences, and informing clinical guidelines and recommendations.

Objective

While Cardiovascular diseases (CVD) are the main cause of death worldwide, they are responsible for half of all deaths in Europe. The overall ageing of the European population and improving survival of patients with coronary heart disease has created a large population of older adults eligible for secondary prevention. Despite the established efficacy of cardiovascular medications, suboptimal adherence reduces their effectiveness and is the primary reason for suboptimal clinical benefit, contributing significantly to worsening of diseases and deaths at the population level. SECURE will be the first trial testing the efficacy of a fixed dose combination (FDC) polypill for secondary cardiovascular prevention in the elderly population (≥ 65 years old). The main objective is to evaluate the potential benefit of the FDC as a component of a cost-effective, globally available and comprehensive treatment strategy for secondary prevention of cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, stroke, and hospitalisation requiring revascularisation) as compared to standard therapy (the three components of the polypill given separately). As part of the secondary endpoints, SECURE will compare the effect of both strategies on adherence and intermediate measures of risk factor control such as lipids and blood pressure. Importantly, it will also measure the pharmacoeconomic impact of the FDC intervention as well as regional differences in all outcomes. The five-year project will thus involve subjects from seven different countries: Spain, Italy, France, Germany, Hungary, Poland and the Czech Republic. The findings and conclusions obtained in SECURE will allow the drafting of clinical guidelines and recommendations that will provide useful guidance and will serve as a reference framework for all stakeholders involved in tackling major challenges related to secondary prevention and treatment of chronic diseases in the elderly population.

Fields of science

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Topic(s)

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-two-stage

Funding Scheme

RIA - Research and Innovation action

Coordinator

CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P.)
Net EU contribution
€ 1 465 972,00
Address
CALLE MELCHOR FERNANDEZ ALMAGRO 3
28029 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
Links
Total cost
€ 1 594 375,00

Participants (11)

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Last update: 7 December 2023

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Permalink: https://cordis.europa.eu/project/id/633765

European Union, 2024