An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers "BRONCE-AP"

Completed

Phase 4 Results N/A

Trial Description

This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)

Conditions

Interventions

  • Xarelto, Pradaxa and Eliquis Drug
    Intervention Desc: Direct oral anticoagulants; Treatment pattern following the summary of product characteristics
    ARM 1: Kind: Experimental
    Label: Direct oral anticoagulants
    Description: patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres

Trial Design

  • Observation: Cohort
  • Perspective: Cross-Sectional
  • Sampling: Non-Probability Sample

Trial Population

patients at risk of stroke or systemic embolism on anticoagulant therapy, who have changed their therapeutic regimen according to their doctor's decision, due to any clinical situation and based on routine clinical practice, and who at the time of enrolment in the study have been receiving treatment with a DOAC for at least three months

Outcomes

Type Measure Time Frame Safety Issue
Primary Age At baseline visit No
Primary Gender At baseline visit No
Primary Race At baseline visit No
Primary Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding At baseline visit Yes
Primary Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia At baseline visit Yes
Primary Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances At baseline visit Yes
Primary Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances At baseline visit Yes
Primary Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances At baseline visit Yes
Primary Concomitant treatments: therapy group of relevant active substances At baseline visit Yes
Primary Risk of thromboembolic event based on the CHADS2 score At baseline visit Yes
Primary Risk of thromboembolic event based on the CHA2DS2-VASc score At baseline visit Yes
Primary Risk of bleeding based on the HAS-BLED score At baseline visit Yes
Secondary Adherence to treatment At baseline visit No
Secondary Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire At baseline visit No
Secondary Compliance with the criteria in therapeutic positioning report UT/V4/23122013 At baseline visit No
Secondary Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF. At baseline visit No

Sponsors