An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres "SILVER-AP"

Completed

Phase N/A Results N/A

Trial Description

describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic regimen, due to any clinical situation, based on the doctor's routine clinical practice and are currently on treatment with a direct oral anticoagulant (DOAC)

Conditions

Interventions

  • Direct oral anticoagulants Drug
    Intervention Desc: Treatment pattern following the summary of product characteristics
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: patients diagnosed with Non-Valvular Atrial Fribilation 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 Composite of demographic characteristics: age, gender and race At baseline visit No
Primary Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding At baseline visit Yes
Primary Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, At baseline visit Yes
Primary Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances At baseline visit Yes
Primary Concomitant treatments: 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 At baseline visit No
Secondary Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico) At baseline visit No

Sponsors