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MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol

Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselec...

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Autores principales: Camporese, Giuseppe, Bernardi, Enrico, Bortoluzzi, Cristiano, Noventa, Franco, Hong, Ngoc Vo, Callegari, Elena, Villalta, Sabina, Tonello, Chiara, Nardin, Michela, Campello, Elena, Spiezia, Luca, Simioni, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876063/
https://www.ncbi.nlm.nih.gov/pubmed/33585500
http://dx.doi.org/10.3389/fmed.2020.584459
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author Camporese, Giuseppe
Bernardi, Enrico
Bortoluzzi, Cristiano
Noventa, Franco
Hong, Ngoc Vo
Callegari, Elena
Villalta, Sabina
Tonello, Chiara
Nardin, Michela
Campello, Elena
Spiezia, Luca
Simioni, Paolo
author_facet Camporese, Giuseppe
Bernardi, Enrico
Bortoluzzi, Cristiano
Noventa, Franco
Hong, Ngoc Vo
Callegari, Elena
Villalta, Sabina
Tonello, Chiara
Nardin, Michela
Campello, Elena
Spiezia, Luca
Simioni, Paolo
author_sort Camporese, Giuseppe
collection PubMed
description Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselected patients given oral anticoagulants for venous thromboembolism, during a 5-year follow-up period. This is a prospective-cohort, multi-center, observational study performed in four Italian centers. The estimated samples size is 4,000 patients. The efficacy outcomes are: incidence of symptomatic recurrent venous thromboembolism and of post-thrombotic syndrome. The safety outcomes are: incidence of major bleeding, clinically relevant non-major bleeding, minor bleeding, serious adverse events, and mortality. The MAC project has the potential to improve our understanding of the epidemiology and of the therapeutic strategies adopted in Italian patients with venous thromboembolism. Clinical Trial Registration: WWW.ClinicalTrials.Gov, identifier: NCT0432939.
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spelling pubmed-78760632021-02-12 MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol Camporese, Giuseppe Bernardi, Enrico Bortoluzzi, Cristiano Noventa, Franco Hong, Ngoc Vo Callegari, Elena Villalta, Sabina Tonello, Chiara Nardin, Michela Campello, Elena Spiezia, Luca Simioni, Paolo Front Med (Lausanne) Medicine Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselected patients given oral anticoagulants for venous thromboembolism, during a 5-year follow-up period. This is a prospective-cohort, multi-center, observational study performed in four Italian centers. The estimated samples size is 4,000 patients. The efficacy outcomes are: incidence of symptomatic recurrent venous thromboembolism and of post-thrombotic syndrome. The safety outcomes are: incidence of major bleeding, clinically relevant non-major bleeding, minor bleeding, serious adverse events, and mortality. The MAC project has the potential to improve our understanding of the epidemiology and of the therapeutic strategies adopted in Italian patients with venous thromboembolism. Clinical Trial Registration: WWW.ClinicalTrials.Gov, identifier: NCT0432939. Frontiers Media S.A. 2021-01-28 /pmc/articles/PMC7876063/ /pubmed/33585500 http://dx.doi.org/10.3389/fmed.2020.584459 Text en Copyright © 2021 Camporese, Bernardi, Bortoluzzi, Noventa, Hong, Callegari, Villalta, Tonello, Nardin, Campello, Spiezia and Simioni. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Camporese, Giuseppe
Bernardi, Enrico
Bortoluzzi, Cristiano
Noventa, Franco
Hong, Ngoc Vo
Callegari, Elena
Villalta, Sabina
Tonello, Chiara
Nardin, Michela
Campello, Elena
Spiezia, Luca
Simioni, Paolo
MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title_full MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title_fullStr MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title_full_unstemmed MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title_short MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol
title_sort mac project—monitoring anticoagulant therapy observational study: rationale and protocol
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876063/
https://www.ncbi.nlm.nih.gov/pubmed/33585500
http://dx.doi.org/10.3389/fmed.2020.584459
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