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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOAC treated patients | Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Oral Anticoagulant (DOAC) | Drug | Treatment pattern following the summary of product characteristics |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at risk of stroke or systemic embolism on anticoagulant therapy, who have changed their therapeutic regimen according to their doctor's decision, due to any clinical situation and based on routine clinical practice, and who at the time of enrolment in the study have been receiving treatment with a DOAC for at least three months
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Spain |
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| 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 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
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