Secondary prEvention of CardiovascUlaR disease in the Elderly trial SECURE
Basic information about the project
Information in English
- SECURE project homepage - www.secure-h2020.eu
Current project status
The SECURE project was launched in 2015 and will run until the end of 2021 (due to the problematic recruitment of patients to the study, the project was extended by 20 months). A consortium of eleven partner research institutions from France, Italy, Hungary, Germany, Poland and Spain participates in the SECURE project, and holds II. internal clinic of the General Hospital the function of the national coordinator, the main examiner in the project is prof. MUDr. Aleš Linhart, DrSc., FESC and the project manager is doc. MUDr. Jean-Claude Lubanda, Ph.D. In addition to the General Hospital in Prague, seven other workplaces in the Czech Republic are participating in this clinical study:
- Na Homolce Hospital, Prague
Major examiner: MUDr. Dagmar Vondráková
- University Hospital Královské Vinohrady, Prague
Major examiner: MUDr. František Bednář Ph.D.
- University Hospital Olomouc
principal examiner: prof. MUDr. Milos Taborsky, CSc., MBA
- Slaný Hospital
Major examiner: MUDr. Ondřej Čermák
- Jihlava Hospital
Major examiner: MUDr. Zdeněk Klimsa
- Podlesí Hospital
Major examiner: MUDr. Libor Škňouřil, Ph.D.
- Liberec Regional Hospital
Major examiner: MUDr. Jiří Karásek
A total of 3206 patients were planned to be enrolled in the study, with more than 96 active centers in Europe to randomize. As of October 31, 2018, active recruitment to the study was completed in the centers of the Czech Republic, France, Hungary and Poland. By the end of recruitment, a total of 174 patients meeting the required demanding criteria were included in the study within the Czech centers, II. The internal clinic of cardiology and angiology, with its number of 71 patients, ranks 4th in the recruitment of patients throughout Europe. With regard to the study protocol approved by the European Union, the follow-up of patients is extended until the end of October 2021 in order to achieve the desired monitoring of the effect of the polypill combination tablet for at least 2 years in all patients. Subsequently, patients will be transferred to standard treatment. The last visits will take place before October 31, 2021.
Centers in Italy, Germany, and Spain continued to actively search for suitable trial subjects for the SECURE project until November 2019. At the end of November 2019, a total of 2,514 patients were randomized to the study and the number was completed.
Annual meeting of investigators from the Czech Republic
In May 2019, a physical meeting took place within the XXVII. annual congress of the Czech Society of Cardiology in Brno in the form of a personal meeting of investigators from all centers cooperating on the SECURE project in the Czech Republic.
These regular meetings serve mainly to communicate significant innovations in the project.
The meeting is always focused mainly on discussing the administrative issues necessary to maintain the current smooth course of this clinical trial in individual centers in the Czech Republic.
In 2020, due to the COVID-19 pandemic, the CCP's annual congress was held only online. Unfortunately, the CCP's annual congress will take place online again in 2021. Therefore, the coordinator decided to schedule a meeting of investigators also online.
The study continues despite the pandemic situation and the medication is delivered to patients by courier without complications.
International meeting of the SECURE consortium
Due to the ongoing pandemic situation, an international meeting of the study consortium was not held in September 2020, where a meeting of project coordinators from all participating countries in Europe took place every year with the participation of Dr. Fustera. In 2021, the meeting is planned to take place online.
On September 2, 2019, the last international meeting of the SECURE consortium, within the congress of the European Society of Cardiology, took place in Paris.
On 27 August 2018, the meeting was attended by a large number of representatives of the participating companies, national coordinating organizations from each country and investigators working on the SECURE clinical trial in European countries. The Czech Republic was represented by representatives of the national project coordinator, Head of II. Department of Internal Medicine, Cardiology and Angiology, General Hospital in Prague prof. MUDr. Aleš Linhart, DrSc. and project coordinator Zuzana Kolářová.
During the workshop, questions about the strategy that would help increase the number of randomized patients, as well as the next clinical trial schedule, were discussed. In particular, the aforementioned termination of patient recruitment in some countries has been addressed, while in selected countries its extension and extension of the follow-up of assessment subjects in accordance with the protocol have been addressed.
SECURE Award and Polypill Medication
During its existence, the project has received several significant awards.
In 2016, the SECURE project received the Best European Cooperation Project award from the Fundación para el conocimiento Madrid. More information can be found at: http://www.secure-h2020.eu/page/posts/secure-awarded-prize-for-best-european-cooperation-project-12.php.
Subsequently, in October 2018, the cardiovascular polypill received an extraordinary award for Best Multidisciplinary Adherence Project at the first annual OAT Awards, see https://www.cnic.es/es/noticias/polipildora-cardiovascular-premiada-como-mejor-proyecto-adherencia-multidisciplinar. This award is given to projects that improve treatment compliance.
In this context, the SECURE project is presented as a study to define the impact of polypill on the prevention of cardiovascular events. In view of the outcome, the study could contribute to updating clinical guidance guidelines to improve secondary prevention in patients with cardiovascular disease worldwide. The advantage of polypill treatment is its simplicity, as patients use one capsule instead of three, resulting in improved treatment compliance for chronic patients of older age.
Press releases on SECURE project
- 20. 3. 2017 The combined tablet will make life easier for the elderly after a heart attack
This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 633765