Stroke, Prevention and Control, Atrial Fibrillation
Conditions
Brief summary
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)
Interventions
Treatment pattern following the summary of product characteristics
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of bleeding based on the HAS-BLED score | At baseline visit | clinical characteristics |
| Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, | At baseline visit | clinical characteristics |
| Risk of thromboembolic event based on the CHA2DS2-VASc score | At baseline visit | clinical characteristics |
| Risk of thromboembolic event based on the CHADS2 score | At baseline visit | clinical characteristics |
| Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances | At baseline visit | clinical characteristics |
| Concomitant treatments: relevant active substances | At baseline visit | clinical characteristics |
| Composite of demographic characteristics: age, gender and race | At baseline visit | sociodemographic data |
| Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding | At baseline visit | clinical characteristics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to treatment | At baseline visit | use of Haynes-Sackett test |
| Satisfaction of treatment | At baseline visit | use of ACTS questionnaire |
| Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico) | At baseline visit | use IPT guideline |
Countries
Spain
Outcome results
None listed