Periodic Reporting for period 6 - CoroPrevention (Personalized Prevention for Coronary Heart Disease)
Berichtszeitraum: 2025-03-01 bis 2025-12-31
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 6th period, the existing training materials were updated to reflect the latest application updates of the CoroPrevention Tool Suite. Currently, CoroPrevention Tool Suite Release 3.2 is available in the following languages: English, Finnish, Portuguese, Greek, German, Polish, Italian and Dutch. The support for Dutch was added during this reporting period. To improve usability of the Tool Suite, a list of improvements across the different applications and modules were selected for implementation in Release 3.3 in Q1-Q2 of 2026. A new version of the Medication Decision Support System (decision trees) was specified and developed for this release to ensure alignment with the latest ESC recommendations and to maintain accurate, up-to-date clinical decision support.
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. Initial regulatory and ethical approval was obtained in Belgium during this reporting period. In Belgium, monitoring is conducted by TAU with support from the local Clinical Trial Center, which acts as a linked third party and is organizationally independent from the national coordinating centre’s trial team. The CRO partners and TAU have conducted site initiation visits at participating clinical sites to ensure that site personnel are sufficiently trained in all study-related procedures and workflows. Monitoring activities are performed both remotely and through periodic on-site visits by the CRA, typically occurring one to two times annually, or more often if necessary. CRAs proactively oversee site management activities to facilitate timely detection and resolution of any issues.
During this reporting period, active enrollment was conducted at four sites in Finland, three in Portugal, two in Poland, three in Germany, three in Greece, and one in Belgium. In total, 16 sites are recruiting patients, including the first Belgian site, which was activated for enrollment on 3 February 2026. Preparations to activate several additional sites are ongoing, and new sites are expected to open for enrollment in the next reporting period. Continued efforts are underway to accelerate enrollment at both currently active sites and those scheduled to open soon.
Data management of the project is ongoing on regular basis by generating reports every two weeks 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 continued to coordinate outreach efforts, including events and webinars, social media engagement, website development, internal communications, scientific publications, and participation in external meetings. A major update to the CoroPrevention website implemented during this reporting period concerned the Trial Patients section, which now includes Dutch as an additional language. The online newsletter dissemination strategy also continued, with newsletters distributed in May 2025, August 2025, and November 2025. In addition, a partners’ newsletter was circulated in January 2026.
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. Initial regulatory and ethical approval was obtained in Belgium during this reporting period. In Belgium, monitoring is conducted by TAU with support from the local Clinical Trial Center, which acts as a linked third party and is organizationally independent from the national coordinating centre’s trial team. The CRO partners and TAU have conducted site initiation visits at participating clinical sites to ensure that site personnel are sufficiently trained in all study-related procedures and workflows. Monitoring activities are performed both remotely and through periodic on-site visits by the CRA, typically occurring one to two times annually, or more often if necessary. CRAs proactively oversee site management activities to facilitate timely detection and resolution of any issues.
During this reporting period, active enrollment was conducted at four sites in Finland, three in Portugal, two in Poland, three in Germany, three in Greece, and one in Belgium. In total, 16 sites are recruiting patients, including the first Belgian site, which was activated for enrollment on 3 February 2026. Preparations to activate several additional sites are ongoing, and new sites are expected to open for enrollment in the next reporting period. Continued efforts are underway to accelerate enrollment at both currently active sites and those scheduled to open soon.
Data management of the project is ongoing on regular basis by generating reports every two weeks 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 continued to coordinate outreach efforts, including events and webinars, social media engagement, website development, internal communications, scientific publications, and participation in external meetings. A major update to the CoroPrevention website implemented during this reporting period concerned the Trial Patients section, which now includes Dutch as an additional language. The online newsletter dissemination strategy also continued, with newsletters distributed in May 2025, August 2025, and November 2025. In addition, a partners’ newsletter was circulated in January 2026.
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.