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

Study Overview
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Brief Summary
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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)

Official Title
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An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers

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 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 .

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 Fibrillation 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 |
| --- | --- | --- |
| Age | sociodemographic data | At baseline visit | 
| Gender | sociodemographic data | At baseline visit | 
| Race | sociodemographic data | At baseline visit | 
| Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding | sociodemographic data | At baseline visit | 
| Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia | clinical characteristics | At baseline visit | 
| Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances | clinical characteristics | At baseline visit | 
| Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances | clinical characteristics | At baseline visit | 
| Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances | clinical characteristics | 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 | At baseline visit | 
| Risk of thromboembolic event based on the CHADS2 score | clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke | 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 | 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 | 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 by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire |  | 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. | 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 | At baseline visit |