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Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study
INTRODUCTION: The risk for stroke in adults with congenital heart disease (ACHD) is increased, especially in the setting of commonly ensuing atrial arrhythmias (AA), namely atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia. Data are limited regarding treatment with non-vitam...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509965/ https://www.ncbi.nlm.nih.gov/pubmed/32963069 http://dx.doi.org/10.1136/bmjopen-2020-038012 |
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author | Kartas, Anastasios Doundoulakis, Ioannis Ntiloudi, Despoina Koutsakis, Athanasios Kosmidis, Diamantis Rampidis, Georgios Apostolopoulou, Sotiria Frogoudaki, Alexandra Tzifa, Afrodite Avramidis, Dimosthenis Ntzoyvara, Olga Liori, Sotiria Mousiama, Tereza Mouratoglou, Sophia Anastasia Karvounis, Haralambos Giannakoulas, George |
author_facet | Kartas, Anastasios Doundoulakis, Ioannis Ntiloudi, Despoina Koutsakis, Athanasios Kosmidis, Diamantis Rampidis, Georgios Apostolopoulou, Sotiria Frogoudaki, Alexandra Tzifa, Afrodite Avramidis, Dimosthenis Ntzoyvara, Olga Liori, Sotiria Mousiama, Tereza Mouratoglou, Sophia Anastasia Karvounis, Haralambos Giannakoulas, George |
author_sort | Kartas, Anastasios |
collection | PubMed |
description | INTRODUCTION: The risk for stroke in adults with congenital heart disease (ACHD) is increased, especially in the setting of commonly ensuing atrial arrhythmias (AA), namely atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia. Data are limited regarding treatment with non-vitamin K oral anticoagulants in long-term studies involving patients with ACHD and AA. METHODS AND ANALYSIS: PReventiOn of ThromboEmbolism in Adults with Congenital HearΤ disease and Atrial aRrhythmias is a prospective, multicenter, single-arm, non-interventional cohort study designed to investigate the safety and efficacy of apixaban for the prevention of thromboembolism in ACHD with AA in a ‘real-world’ setting. Eligible patients will be evaluated by the means of available registries and clinical counter. The study aims to accumulate approximately 500 patient-years of exposure to apixaban as part of routine care. Enrolment will take place at four ACHD centres in Greece. The first patient was enrolled in July 2019. The primary efficacy endpoint is a composite of stroke, systemic or pulmonary embolism and intracardiac thrombosis. The primary safety endpoint is major bleeding, according to the International Society on Thrombosis and Haemostasis bleeding criteria. ETHICS AND DISSEMINATION: The study protocol has been approved by the institutional review board/independent ethics committee at each site prior to study commencement. All patients will provide written informed consent. Results will be disseminated at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03854149; Pre-results. |
format | Online Article Text |
id | pubmed-7509965 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-75099652020-10-05 Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study Kartas, Anastasios Doundoulakis, Ioannis Ntiloudi, Despoina Koutsakis, Athanasios Kosmidis, Diamantis Rampidis, Georgios Apostolopoulou, Sotiria Frogoudaki, Alexandra Tzifa, Afrodite Avramidis, Dimosthenis Ntzoyvara, Olga Liori, Sotiria Mousiama, Tereza Mouratoglou, Sophia Anastasia Karvounis, Haralambos Giannakoulas, George BMJ Open Cardiovascular Medicine INTRODUCTION: The risk for stroke in adults with congenital heart disease (ACHD) is increased, especially in the setting of commonly ensuing atrial arrhythmias (AA), namely atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia. Data are limited regarding treatment with non-vitamin K oral anticoagulants in long-term studies involving patients with ACHD and AA. METHODS AND ANALYSIS: PReventiOn of ThromboEmbolism in Adults with Congenital HearΤ disease and Atrial aRrhythmias is a prospective, multicenter, single-arm, non-interventional cohort study designed to investigate the safety and efficacy of apixaban for the prevention of thromboembolism in ACHD with AA in a ‘real-world’ setting. Eligible patients will be evaluated by the means of available registries and clinical counter. The study aims to accumulate approximately 500 patient-years of exposure to apixaban as part of routine care. Enrolment will take place at four ACHD centres in Greece. The first patient was enrolled in July 2019. The primary efficacy endpoint is a composite of stroke, systemic or pulmonary embolism and intracardiac thrombosis. The primary safety endpoint is major bleeding, according to the International Society on Thrombosis and Haemostasis bleeding criteria. ETHICS AND DISSEMINATION: The study protocol has been approved by the institutional review board/independent ethics committee at each site prior to study commencement. All patients will provide written informed consent. Results will be disseminated at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03854149; Pre-results. BMJ Publishing Group 2020-09-22 /pmc/articles/PMC7509965/ /pubmed/32963069 http://dx.doi.org/10.1136/bmjopen-2020-038012 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Cardiovascular Medicine Kartas, Anastasios Doundoulakis, Ioannis Ntiloudi, Despoina Koutsakis, Athanasios Kosmidis, Diamantis Rampidis, Georgios Apostolopoulou, Sotiria Frogoudaki, Alexandra Tzifa, Afrodite Avramidis, Dimosthenis Ntzoyvara, Olga Liori, Sotiria Mousiama, Tereza Mouratoglou, Sophia Anastasia Karvounis, Haralambos Giannakoulas, George Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title | Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title_full | Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title_fullStr | Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title_full_unstemmed | Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title_short | Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study |
title_sort | rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the protect-ar study |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509965/ https://www.ncbi.nlm.nih.gov/pubmed/32963069 http://dx.doi.org/10.1136/bmjopen-2020-038012 |
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