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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOAC treated patients | Patients diagnosed with Non-Valvular Atrial Fibrillation 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 |
|---|---|---|
| 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 |
| 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 |
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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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| 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 |
| 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 |
| 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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