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

NCT02470767 — Completed, 792 participants, Bayer

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Registry	NCT02470767, acronym SILVER-AP
Status	Completed
Study type	Observational
Enrollment	792 (Actual)
Sponsor	Bayer (Industry)
Conditions	Stroke, Prevention and Control, Atrial Fibrillation
Interventions	Direct Oral Anticoagulant (DOAC) (Drug)
Dates	start 2015-05-01, primary completion 2015-12-01, completion 2016-03-01, first posted 2015-06-12, last updated 2017-02-16
Locations	1 site in Spain

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
DOAC treated patients		Drug: Direct Oral Anticoagulant (DOAC)	Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC.

Direct Oral Anticoagulant (DOAC) (Drug): Treatment pattern following the summary of product characteristics

+Outcome measures

Primary outcomes

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

Secondary outcomes

Adherence to treatment [At baseline visit]: use of Haynes-Sackett test
Satisfaction of treatment [At baseline visit]: use of ACTS questionnaire
Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico) [At baseline visit]: use IPT guideline

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
	Many Locations	Spain

+Investigators

Bayer Study Director, Study director, Bayer

My Notes

Public

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