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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Stroke, Prevention and Control, Atrial Fibrillation

Intervention / Treatment
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* Drug: Direct Oral Anticoagulant (DOAC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DOAC treated patients<br>Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC. | Drug: Direct Oral Anticoagulant (DOAC)<br>* Treatment pattern following the summary of product characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of demographic characteristics: age, gender and race | sociodemographic data | At baseline visit | 
| Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding | clinical characteristics | At baseline visit | 
| Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, | clinical characteristics | At baseline visit | 
| Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances | clinical characteristics | At baseline visit | 
| Concomitant treatments: relevant active substances | clinical characteristics | At baseline visit | 
| Risk of thromboembolic event based on the CHADS2 score | clinical characteristics | At baseline visit | 
| Risk of thromboembolic event based on the CHA2DS2-VASc score | clinical characteristics | At baseline visit | 
| Risk of bleeding based on the HAS-BLED score | clinical characteristics | At baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment | use of Haynes-Sackett test | At baseline visit | 
| Satisfaction of treatment | use of ACTS questionnaire | 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 | At baseline visit |