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

Bayer247 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

247

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 non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres. * Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent). * Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care. * 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 non-valvular atrial fibrillation with a direct oral anticoagulant .

Outcomes

Primary Outcomes

Age

sociodemographic data

Time frame: At baseline visit

Gender

sociodemographic data

Time frame: At baseline visit

Race

sociodemographic data

Time frame: At baseline visit

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

sociodemographic data

Time frame: At baseline visit

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

clinical characteristics

Time frame: At baseline visit

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

clinical characteristics

Time frame: At baseline visit

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

clinical characteristics

Time frame: At baseline visit

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

clinical characteristics

Time frame: At baseline visit

Concomitant treatments: therapy group of relevant active substances

clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify

Time frame: At baseline visit

Risk of thromboembolic event based on the CHADS2 score

clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke

Time frame: At baseline visit

Risk of thromboembolic event based on the CHA2DS2-VASc score

clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category

Time frame: At baseline visit

Risk of bleeding based on the HAS-BLED score

clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly

Time frame: At baseline visit

Secondary Outcomes

Adherence to treatment

use of Haynes-Sackett test

Time frame: At baseline visit

Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire

Time frame: At baseline visit

Compliance with the criteria in therapeutic positioning report UT/V4/23122013

In some Spanish regions it is mandatory to accomplish the conditions of the national guideline UT/V4/23122013 regarding the use of direct oral anticoagulant. In that guideline the characteristics of patients candidates to direct oral anticoagulant are explained.

Time frame: At baseline visit

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.

Healthcare resources

Time frame: At baseline visit

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes