Many Locations, Spain
NCT Number: NCT02470767
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
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Direct Oral Anticoagulant (DOAC)
DrugTreatment pattern following the summary of product characteristics
Primary outcomes
-
Composite of demographic characteristics: age, gender and race
Time frame: At baseline visit
sociodemographic data
-
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
Time frame: At baseline visit
clinical characteristics
-
Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,
Time frame: At baseline visit
clinical characteristics
-
Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
Time frame: At baseline visit
clinical characteristics
-
Concomitant treatments: relevant active substances
Time frame: At baseline visit
clinical characteristics
-
Risk of thromboembolic event based on the CHADS2 score
Time frame: At baseline visit
clinical characteristics
-
Risk of thromboembolic event based on the CHA2DS2-VASc score
Time frame: At baseline visit
clinical characteristics
-
Risk of bleeding based on the HAS-BLED score
Time frame: At baseline visit
clinical characteristics
Secondary outcomes
-
Adherence to treatment
Time frame: At baseline visit
use of Haynes-Sackett test
-
Satisfaction of treatment
Time frame: 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)
Time frame: At baseline visit
use IPT guideline
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Acronym: SILVER-AP
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Jun 12, 2015
- Registry last updated
- Feb 16, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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