SECURE Project

Basic information about the project

Information in English

Current project status

The SECURE project was launched in 2015 and will run until 2020. A consortium of eleven partner research institutions from France, Italy, Hungary, Germany, Poland and Spain is participating in the SECURE project, with II in the Czech Republic. Internal Clinic of the General Teaching Hospital the function of national coordinator, the principal investigator in the project is the head of prof. MUDr. Aleš Linhart, DrSc., FESC and project manager are doc. MUDr. Jean-Claude Lubanda, Ph.D. In addition to the General Teaching Hospital in Prague, seven other research centers participate in this clinical study in the Czech Republic:

  • 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 enrolled in the study, with more than 96 active centers involved in randomization. As of 31 October 2018, active recruitment for study in the Czech Republic, France, Hungary and Poland was completed. Up to the end of the recruitment process, a total of 174 patients meeting the required demanding criteria were included in the Czech Centers, II. The Internal Clinic of Cardiology and Angiology, with 71 patients, ranks 4th in patient recruitment across Europe. Taking into account the study protocol approved by the European Union, the follow-up of patients until the end of 2020 is extended to achieve the desired monitoring of the effect of the polypill tablet for at least 2 years.

Centers in Italy, Germany and Spain continue to actively seek out suitable subjects for SECURE until November 2019. A total of 2209 patients were randomized to study at the end of May 2019.

Annual meeting of investigators from the Czech Republic

In May 2019, it took place under XXVII. of the Annual Congress of the Czech Society of Cardiology in Brno, a personal meeting of investigators from all centers cooperating on the SECURE project within the Czech Republic.

These regular meetings serve mainly to convey substantial news in the project.

This year, the meeting was mainly focused on discussing administrative issues necessary to maintain the smooth running of this clinical trial in individual centers in the Czech Republic. The present participants managed to develop a rich discussion, which was mainly focused on the future of the project and the conduct of study visits even after the end of active recruitment.

It was also recalled that, although there is no longer any need to search for and randomize patients, the project is still active, and it is necessary to continue error-free patient monitoring according to the current protocol.

International meeting of the SECURE consortium

On September 2, 2019, an international meeting of the SECURE consortium is scheduled to take place as part of the congress of the European Society of Cardiology, this time in Paris.

Last year, the meeting took place on 27 August 2018 with the participation of representatives of participating companies, national coordinating organizations from countries and investigators working together in the SECURE clinical trial in European countries. The Czech Republic was represented by representatives of the National Project Coordinator, Head of II. Internal Clinic of Cardiology and Angiology, General University Hospital, 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
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