Vol 5, No 4 (2020)
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Published online: 2020-11-20

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The rationale for Multilevel Educational and Motivational Intervention in Patients after Myocardial Infarction (MEDMOTION) project is to support multicentre randomized clinical trial Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome (ELECTRA – SIRIO 2)

Aldona Kubica1, Piotr Adamski2, Anna Bączkowska3, Damian Czarnecki4, Tomasz Derewiecki5, Rafał Donderski6, Elżbieta Grzechowiak7, Małgorzata Jasiewicz2, Andrzej Kleinrok58, Grzegorz Kozera9, Piotr Michalski1, Beata Sulikowska6, Ewa Szeremeta5, Julia Umińska10, Katarzyna Ulaszewska7, Marcin Ziółkowski4, Jacek Kubica2
Medical Research Journal 2020;5(4):244-249.

Abstract

The Multilevel Educational and Motivational Intervention in Patients after Myocardial Infarction (MEDMOTION) project will be adopted to support adherence to the study treatment in the Evaluation Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome (ELECTRA-SIRIO 2) a randomized clinical trial.

A prespecified sub-analysis of the ELECTRA-SIRIO 2 trial will be performed to evaluate the impact of the results of MEDMOTION diagnostic questionnaires on the clinical outcomes.

The study population will comprise of 4,500 patients consecutively admitted to the study centres due to acute coronary syndrome. The MEDMOTION project involves the following interventions: patients’ education, motivation, reminding to take medications and to attend consecutive medical appointments. Dedicated questionnaires will be applied to diagnose study participants with regard to their readiness for discharge from the hospital at the end of initial hospitalization, the risk of non-adherence to the medication at the end of 3rd and 12th month of follow up, and the functioning in disease at the end of 3rd and 12th month of follow up. The primary safety composite endpoint of this study is type 2, 3 or 5 bleeding according to the BARC criteria, occurring during the first 12 months after ACS. The primary efficacy endpoint is the composite of death from any cause, the first nonfatal MI, or the first nonfatal stroke. The key secondary endpoint, net clinical effect, was defined as the composite of death from any cause, a nonfatal MI or a nonfatal stroke, and the first occurrence of BARC type 2, 3, or 5 bleeding.

Concluding, it is expected that the comprehensive approach designed in the MEDMOTION project, including use of diagnostic questionnaires, will significantly contribute to obtaining a high level of adherence to medication and improving clinical outcomes in the ELECTRA-SIRIO 2 trial.

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