Periodic Reporting for period 5 - CoroPrevention (Personalized Prevention for Coronary Heart Disease)
Période du rapport: 2024-03-01 au 2025-02-28
European Coronary Heart Disease (CHD) burden is unsustainable. Better risk stratification tools and personalized care of patients are needed for reducing morbidity and mortality of CHD and the associated economic burden. To this end we have planned to shape and implement a personalized secondary prevention program for patients with established CHD. This precision strategy will be tested in a prospective trial, the CoroPrevention Trial, a central element of our project. We aim to significantly reduce the numbers of coronary events by using outcome risk- and patient characteristics- guided prevention in CHD patients.
1. Prospectively evaluate clinical utility of personalized prevention in CHD
2. Evaluate health economic and social benefits of the personalized prevention in CHD
3. Discover predictive markers of drug treatment response in CHD
4. Improve current ESC guidelines based on RCT validated clinical data
5. Disseminate the refined prevention program to the attention of practitioners, patients, health care payers and policy makers
This program will establish a new economically sustainable personalized treatment practice applicable throughout Europe particularly to those regions where CHD prevention needs upgrading. The used protocols and technologies will carefully be assessed by NICE using their standard evaluation methods that will allow independent expert opinions for different European authorities and decision makers. These opinion statements will further be supported by full Health Economics analyses of CoroPrevention Trial.
1. Prospectively evaluate clinical utility of personalized prevention in CHD
2. Evaluate health economic and social benefits of the personalized prevention in CHD
3. Discover predictive markers of drug treatment response in CHD
4. Improve current ESC guidelines based on RCT validated clinical data
5. Disseminate the refined prevention program to the attention of practitioners, patients, health care payers and policy makers
This program will establish a new economically sustainable personalized treatment practice applicable throughout Europe particularly to those regions where CHD prevention needs upgrading. The used protocols and technologies will carefully be assessed by NICE using their standard evaluation methods that will allow independent expert opinions for different European authorities and decision makers. These opinion statements will further be supported by full Health Economics analyses of CoroPrevention Trial.
During the fifth reporting period, the CoroPrevention Tool suite was updated with improvements to the existing modules and the addition of last two modules: Smoke-Free Living and Stress-Relief. These new modules were tested during user acceptance testing (UAT) and summative testing by partners. The updated version of Tool suite has been reviewed by the ethics committees (EC) and regulatory authorities (CA) in Finland, Germany, Greece, Poland and Portugal, and relevant approvals have been obtained. The production deployment for tool suite Release 3.2 will be in the beginning of the next reporting period (March 2025). For the key updates to the tool Suite, sites were supported by training session for site personnel and Hub nurses. Additionally, online training and support were provided to the site personnel and will continue.
Trial sponsor TAU in co-operation with CRO partners, Optimapharm and VectorB2B, is ensuring smooth execution of the CoroPrevention trial. Compliance with ethical and legal requirements, including approvals from EC and CA in the participating countries, has been maintained throughout the reporting period and continuous to be upheld. Submission of required documents to both EC and CA, along with site management activities in Finland, Germany, Greece, and Poland is managed by Optimapharm CRO whereas Vector B2B is responsible for these activities in Portugal and Italy. Both Optimapharm and VectorB2B have identified the local submission experts and / or CRAs (Clinical Research Associates) in their respective countries. During this reporting period full CA and EC approval were received for Finland, Germany, Greece, Poland and Portugal. In Italy, response to EC questions was submitted on February 2025 and CA submission will be completed upon favorable EC opinion.
During this reporting period four sites in Finland, three sites in Portugal and one site in both Poland and Germany were actively enrolling subjects. A site initiation visit for a new site in Germany was completed in February 2025. Site activation is ongoing for four sites in Greece and one in Poland, and these sites are expected to start the trial in Q1 2025. Ongoing efforts are in place to accelerate enrollment at both existing sites and the new sites scheduled to open soon.
Data management of the project is ongoing on regular basis by generating reports every two week and as necessary. The data entered in the EDC is quality controlled regularly in secure TAU environment. During this reporting period, security review meetings between TAU and Uniweb were held multiples times. No major issues were encountered, ensuring integrity or availability of the data. Endpoint collection and planning for Interim analysis of the data is ongoing.
The European Society of Cardiology (ESC) continues to lead communication and dissemination efforts for CoroPrevention. During this reporting period, ESC has actively coordinated various outreach activities including events and webinars, social media engagement (LinkedIn, Twitter and YouTube), webpage updates, internal news, publications, external meetings and staff educational sessions. In December 2024, the project’s communication and dissemination strategy plan was updated to enhance visibility and involvement. Online internal newsletters were distributed in July and December 2024, as well as in February 2025. Efforts are underway to increase frequency of newsletter as the trial progresses, aiming to support site participation and accelerate enrollment.
Project management work has progressed according to the plan despite the delays in the project activities. Project coordinator has submitted the planned six deliverables during this reporting period.
Trial sponsor TAU in co-operation with CRO partners, Optimapharm and VectorB2B, is ensuring smooth execution of the CoroPrevention trial. Compliance with ethical and legal requirements, including approvals from EC and CA in the participating countries, has been maintained throughout the reporting period and continuous to be upheld. Submission of required documents to both EC and CA, along with site management activities in Finland, Germany, Greece, and Poland is managed by Optimapharm CRO whereas Vector B2B is responsible for these activities in Portugal and Italy. Both Optimapharm and VectorB2B have identified the local submission experts and / or CRAs (Clinical Research Associates) in their respective countries. During this reporting period full CA and EC approval were received for Finland, Germany, Greece, Poland and Portugal. In Italy, response to EC questions was submitted on February 2025 and CA submission will be completed upon favorable EC opinion.
During this reporting period four sites in Finland, three sites in Portugal and one site in both Poland and Germany were actively enrolling subjects. A site initiation visit for a new site in Germany was completed in February 2025. Site activation is ongoing for four sites in Greece and one in Poland, and these sites are expected to start the trial in Q1 2025. Ongoing efforts are in place to accelerate enrollment at both existing sites and the new sites scheduled to open soon.
Data management of the project is ongoing on regular basis by generating reports every two week and as necessary. The data entered in the EDC is quality controlled regularly in secure TAU environment. During this reporting period, security review meetings between TAU and Uniweb were held multiples times. No major issues were encountered, ensuring integrity or availability of the data. Endpoint collection and planning for Interim analysis of the data is ongoing.
The European Society of Cardiology (ESC) continues to lead communication and dissemination efforts for CoroPrevention. During this reporting period, ESC has actively coordinated various outreach activities including events and webinars, social media engagement (LinkedIn, Twitter and YouTube), webpage updates, internal news, publications, external meetings and staff educational sessions. In December 2024, the project’s communication and dissemination strategy plan was updated to enhance visibility and involvement. Online internal newsletters were distributed in July and December 2024, as well as in February 2025. Efforts are underway to increase frequency of newsletter as the trial progresses, aiming to support site participation and accelerate enrollment.
Project management work has progressed according to the plan despite the delays in the project activities. Project coordinator has submitted the planned six deliverables during this reporting period.
In 2060, some 155 million Europeans are projected to be of age 65 or over. Those aged 65 and over will become a much larger share (rising from 18% now to 28% in 2060 of the population). These demographic changes are expected to have substantial consequences for public finances in the EU and thus public spending on long-term care is projected to double, increasing from 1.8% of GDP in 2010 to 3.4% of GDP in 2060 in the EU as a whole22. Given the high prevalence of CHD and continuously aging population in Europe, the prevention of morbidity and mortality in patients with established CHD is a major public health objective and the focus of this project. We aim to significantly reduce the numbers of destructive and expensive events, namely, cardiovascular deaths, myocardial infarctions (MI) and heart failure hospitalizations by using outcome risk- and patient characteristics- guided prevention in CHD patients. Since majority of CHD patients remain stable throughout their life, it is likely to be useful to focus limited health care resources particularly to those who are the most vulnerable. Catching these individuals and preventing their next potential event will be key to reduce individual harm and societal expenses.