A mixed methodology, non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke associated with non-valvular atrial fibrillation: study protocol.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968555 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2377 (Electronic) Linking ISSN: 14712377 NLM ISO Abbreviation: BMC Neurol Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Anticoagulants/*therapeutic use ; Atrial Fibrillation/*complications ; Brain Ischemia/*etiology ; Stroke/*etiology; Administration, Oral ; Humans ; Prospective Studies ; Pyrazoles/administration & dosage ; Pyridines/administration & dosage ; Pyridones/administration & dosage ; Retrospective Studies ; Rivaroxaban/administration & dosage ; Thiazoles/administration & dosage ; United Kingdom
    • Abstract:
      Background: Treatment with anticoagulants, including direct oral anticoagulants (DOACs), should be considered for patients diagnosed with atrial fibrillation (AF) deemed at risk of ischaemic stroke. There are limited real world data related to the characteristics of patients with non-valvular AF who were not taking anticoagulants at the time of first ischaemic stroke and their subsequent DOAC treatment for the secondary prevention of stroke. Furthermore, little is known about patient adherence and experiences of DOAC treatment, especially for patients with non-valvular AF receiving DOAC therapy for the secondary prevention of stroke.
      Methods: This is a UK mixed methodology, non-interventional study, involving retrospective and prospective medical record reviews and a prospective patient survey, in progress in six UK National Health Service secondary/tertiary care centres. The study comprises two groups of patients. Group 1 will include 300 eligible consenting patients with a first ischaemic stroke associated with non-valvular AF untreated with anticoagulants in the 12 months prior to stroke. Group 2 will include a subgroup of 150 patients from Group 1 initiated on one of the DOACs targeting activated Factor X (n = 50 on apixaban, n = 50 on edoxaban and n = 50 on rivaroxaban). The primary endpoint of the study is the CHA 2 DS 2 -VASc Risk Score prior to initiation of anticoagulation for patients included in Group 1. Secondary endpoints to be evaluated in Group 1 include patient demographics, clinical characteristics, relevant medical history, anticoagulant therapy initiated for secondary prevention of stroke, and relevant concomitant medication. Secondary endpoints to be evaluated in Group 2 include the time between stroke and DOAC initiation; prescribing of DOACs, other anticoagulants and concomitant medication; clinical assessments and hospital resource use; patient reported outcome measures, including the Morisky Medication Adherence Scale questionnaire and the Treatment Satisfaction Questionnaire for Medication.
      Discussion: This mixed methodology study will provide new real world insights into the characteristics and management pathways and patient-reported experiences of this important group of patients. It is anticipated that the results of this study will provide the medical community and patients with important information to inform clinical decision-making and help facilitate meaningful improvements in the care of patients with non-valvular AF.
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    • Contributed Indexing:
      Keywords: Anticoagulant; CHA2DS2-VASc risk score; Direct oral anticoagulants; Hospital resource use; Ischaemic stroke; Non-valvular atrial fibrillation; Treatment adherence; Treatment satisfaction
    • Accession Number:
      0 (Anticoagulants)
      0 (Pyrazoles)
      0 (Pyridines)
      0 (Pyridones)
      0 (Thiazoles)
      3Z9Y7UWC1J (apixaban)
      9NDF7JZ4M3 (Rivaroxaban)
      NDU3J18APO (edoxaban)
    • Publication Date:
      Date Created: 20191201 Date Completed: 20200217 Latest Revision: 20200217
    • Publication Date:
      20240104
    • Accession Number:
      PMC6884790
    • Accession Number:
      10.1186/s12883-019-1530-0
    • Accession Number:
      31783738