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

Bayer792 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

792

Conditions

Stroke Prevention and Control Atrial Fibrillation

Interventions

Direct Oral Anticoagulant (DOAC)DRUG

Treatment pattern following the summary of product characteristics

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥18 years of age diagnosed with NVAF with a risk of stroke or systemic embolism treated in primary care centres. * Patients on regular treatment with anticoagulants who have changed their ther-apeutic regimen due to any clinical situation and have been on treatment with a DOAC for at least three months before being recruited (date of signing the in-formed consent). * Patients whose DOAC has been indicated by the primary care physician. * Patients who have given their informed consent in writing. Exclusion Criteria: * Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent. * Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires. * Patients who started anticoagulant therapy for NVAF with a DOAC.

Outcomes

Primary Outcomes

Composite of demographic characteristics: age, gender and race

sociodemographic data

Time frame: At baseline visit

Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding

clinical characteristics

Time frame: At baseline visit

Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,

clinical characteristics

Time frame: At baseline visit

Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances

clinical characteristics

Time frame: At baseline visit

Concomitant treatments: relevant active substances

clinical characteristics

Time frame: At baseline visit

Risk of thromboembolic event based on the CHADS2 score

clinical characteristics

Time frame: At baseline visit

Risk of thromboembolic event based on the CHA2DS2-VASc score

clinical characteristics

Time frame: At baseline visit

Risk of bleeding based on the HAS-BLED score

clinical characteristics

Time frame: At baseline visit

Secondary Outcomes

Adherence to treatment

use of Haynes-Sackett test

Time frame: At baseline visit

Satisfaction of treatment

use of ACTS questionnaire

Time frame: At baseline visit

Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)

use IPT guideline

Time frame: At baseline visit

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes