PMID- 31843852
OWN - NLM
STAT- MEDLINE
DCOM- 20201209
LR  - 20221222
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 9
IP  - 12
DP  - 2019 Dec 15
TI  - Murcia atrial fibrillation project II: protocol for a prospective observational 
      study in patients with atrial fibrillation.
PG  - e033712
LID - 10.1136/bmjopen-2019-033712 [doi]
LID - e033712
AB  - INTRODUCTION: Atrial fibrillation (AF) is characterised by a high stroke risk. 
      Vitamin K antagonists (VKAs) are the most commonly used oral anticoagulants 
      (OACs) in Spain, but their efficacy and safety depend on the time in therapeutic 
      range of International Normalized Ratio (INR) 2.0-3.0 over 65%-70%. 
      Unfortunately, the difficulties of maintaining an optimal level of 
      anticoagulation and the complications of VKAs (particularly haemorrhagic ones), 
      frequently lead to cessation of this therapy, which has been associated with 
      higher risk of adverse events (AEs), including ischaemic stroke. Our aims are as 
      follows: (1) to evaluate the quality of oral anticoagulation with VKAs, the 
      prevalence of poor quality of anticoagulation, and to identify factors 
      predisposing to poor quality anticoagulation; and (2) to identify patients who 
      will stop OAC and to investigate what factors influence the decision of OAC 
      withdrawal. METHODS AND ANALYSIS: Prospective observational cohort study 
      including outpatients newly diagnosed with AF and naive for OACs from July 2016 
      to June 2018 in an anticoagulation clinic. Patients with prosthetic heart valves, 
      rheumatic mitral valves or valvular AF will be excluded. Follow-up will extend 
      for up to 3 years. During this period, the INR results and changes in the 
      anticoagulant therapy will be recorded, as well as all AEs, or any other 
      information that would be relevant to the proper conduct of research. ETHICS AND 
      DISSEMINATION: All patients were informed about the nature and purpose of the 
      study, and the protocol was approved by the Ethics Committee of Hospital General 
      Universitario Morales Meseguer (reference: EST:20/16). This is an observational 
      study focusing on 'real life' practice and therefore all treatments and follow-up 
      will be performed in accordance to the routine clinical practice with no specific 
      interventions or visits. The results of our study will be disseminated by 
      presentations at national and international meetings, and publications in 
      peer-reviewed journals.
CI  - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Rivera-Caravaca, Jose Miguel
AU  - Rivera-Caravaca JM
AUID- ORCID: 0000-0003-0492-6241
AD  - Deparment of Cardiology, Hospital Clinico Universitario Virgen de la Arrixaca, 
      University of Murcia, Instituto Murciano de Investigacion Biosanitaria 
      (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
FAU - Marin, Francisco
AU  - Marin F
AUID- ORCID: 0000-0001-7246-7708
AD  - Deparment of Cardiology, Hospital Clinico Universitario Virgen de la Arrixaca, 
      University of Murcia, Instituto Murciano de Investigacion Biosanitaria 
      (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
FAU - Esteve-Pastor, Maria Asuncion
AU  - Esteve-Pastor MA
AUID- ORCID: 0000-0003-3104-3460
AD  - Deparment of Cardiology, Hospital Clinico Universitario Virgen de la Arrixaca, 
      University of Murcia, Instituto Murciano de Investigacion Biosanitaria 
      (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
FAU - Galvez, Josefa
AU  - Galvez J
AD  - Department of Hematology and Clinical Oncology, Hospital General Universitario 
      Morales Meseguer, University of Murcia, Instituto Murciano de Investigacion 
      Biosanitaria (IMIB-Arrixaca), Murcia, Spain.
FAU - Lip, Gregory Y H
AU  - Lip GYH
AUID- ORCID: 0000-0002-7566-1626
AD  - Liverpool Centre for Cardiovascular Science, University of Liverpool and 
      Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.
AD  - Department of Clinical Medicine, Aalborg Thrombosis Research Unit, Aalborg 
      University, Aalborg, Denmark.
FAU - Vicente, Vicente
AU  - Vicente V
AD  - Department of Hematology and Clinical Oncology, Hospital General Universitario 
      Morales Meseguer, University of Murcia, Instituto Murciano de Investigacion 
      Biosanitaria (IMIB-Arrixaca), Murcia, Spain.
FAU - Roldan, Vanessa
AU  - Roldan V
AUID- ORCID: 0000-0002-4945-6602
AD  - Department of Hematology and Clinical Oncology, Hospital General Universitario 
      Morales Meseguer, University of Murcia, Instituto Murciano de Investigacion 
      Biosanitaria (IMIB-Arrixaca), Murcia, Spain vroldans@um.es.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191215
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Anticoagulants)
RN  - 12001-79-5 (Vitamin K)
SB  - IM
EIN - BMJ Open. 2022 Dec 22;12(12):e033712corr1. PMID: 36549750
MH  - Administration, Oral
MH  - Anticoagulants/administration & dosage/adverse effects/*therapeutic use
MH  - Atrial Fibrillation/*drug therapy
MH  - Hemorrhage/chemically induced
MH  - Humans
MH  - International Normalized Ratio
MH  - Observational Studies as Topic
MH  - Prospective Studies
MH  - Research Design
MH  - Spain
MH  - Stroke/prevention & control
MH  - Vitamin K/*antagonists & inhibitors
PMC - PMC6924708
OTO - NOTNLM
OT  - Stroke
OT  - atrial fibrillation
OT  - haemorrhage
OT  - mortality
OT  - vitamin K antagonists
COIS- Competing interests: None declared.
EDAT- 2019/12/18 06:00
MHDA- 2020/12/15 06:00
PMCR- 2019/12/12
CRDT- 2019/12/18 06:00
PHST- 2019/12/18 06:00 [entrez]
PHST- 2019/12/18 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2019/12/12 00:00 [pmc-release]
AID - bmjopen-2019-033712 [pii]
AID - 10.1136/bmjopen-2019-033712 [doi]
PST - epublish
SO  - BMJ Open. 2019 Dec 15;9(12):e033712. doi: 10.1136/bmjopen-2019-033712.