MAC Project-Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol.
anticoagulants
deep vein thrombosis
direct oral anticoagulant
monitoring
pulmonary embolism
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2020
2020
Historique:
received:
17
07
2020
accepted:
16
12
2020
entrez:
15
2
2021
pubmed:
16
2
2021
medline:
16
2
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 33585500
doi: 10.3389/fmed.2020.584459
pmc: PMC7876063
doi:
Banques de données
ClinicalTrials.gov
['NCT00432939']
Types de publication
Journal Article
Langues
eng
Pagination
584459Informations de copyright
Copyright © 2021 Camporese, Bernardi, Bortoluzzi, Noventa, Hong, Callegari, Villalta, Tonello, Nardin, Campello, Spiezia and Simioni.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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