An observational study in Stroke, Prevention and Control and Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Bayer · Observational
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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This study's enrollment of 792 is above the median of 160 across 1,692 observational studies indexed under Stroke.
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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
Exclusion Criteria:
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)
Treatment pattern following the summary of product characteristics
Composite of demographic characteristics: age, gender and race
sociodemographic data
Time frame: At baseline visit
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
clinical characteristics
Time frame: At baseline visit
Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,
clinical characteristics
Time frame: At baseline visit
Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
clinical characteristics
Time frame: At baseline visit
Concomitant treatments: relevant active substances
clinical characteristics
Time frame: At baseline visit
Risk of thromboembolic event based on the CHADS2 score
clinical characteristics
Time frame: At baseline visit
Risk of thromboembolic event based on the CHA2DS2-VASc score
clinical characteristics
Time frame: At baseline visit
Risk of bleeding based on the HAS-BLED score
clinical characteristics
Time frame: At baseline visit
Adherence to treatment
use of Haynes-Sackett test
Time frame: At baseline visit
Satisfaction of treatment
use of ACTS questionnaire
Time frame: 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
Time frame: At baseline visit
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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