Trial Condition(s):
Stroke, prevention and control, Atrial Fibrillation
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 (SILVER-AP)
Bayer Identifier:
17964
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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)
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Composite of demographic characteristics: age, gender and racesociodemographic dataTimeframe: At baseline visit
- Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleedingclinical characteristicsTimeframe: At baseline visit
- Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,clinical characteristicsTimeframe: At baseline visit
- Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substancesclinical characteristicsTimeframe: At baseline visit
- Concomitant treatments: relevant active substancesclinical characteristicsTimeframe: At baseline visit
- Risk of thromboembolic event based on the CHADS2 scoreclinical characteristicsTimeframe: At baseline visit
- Risk of thromboembolic event based on the CHA2DS2-VASc scoreclinical characteristicsTimeframe: At baseline visit
- Risk of bleeding based on the HAS-BLED scoreclinical characteristicsTimeframe: At baseline visit
Secondary Outcome
- Adherence to treatmentuse of Haynes–Sackett testTimeframe: At baseline visit
- Satisfaction of treatmentuse of ACTS questionnaireTimeframe: At baseline visit
- Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)use IPT guidelineTimeframe: At baseline visit
Additional Information
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