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

Stroke Clinical Trial

— SILVER-AP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470767
• Other study ID #: 17964
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: February 15, 2017
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 792
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Prevention and Control
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of demographic characteristics: age, gender and race	sociodemographic data	At baseline visit
Primary	Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding	clinical characteristics	At baseline visit
Primary	Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,	clinical characteristics	At baseline visit
Primary	Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Primary	Concomitant treatments: relevant active substances	clinical characteristics	At baseline visit
Primary	Risk of thromboembolic event based on the CHADS2 score	clinical characteristics	At baseline visit
Primary	Risk of thromboembolic event based on the CHA2DS2-VASc score	clinical characteristics	At baseline visit
Primary	Risk of bleeding based on the HAS-BLED score	clinical characteristics	At baseline visit
Secondary	Adherence to treatment	use of Haynes-Sackett test	At baseline visit
Secondary	Satisfaction of treatment	use of ACTS questionnaire	At baseline visit
Secondary	Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)	use IPT guideline	At baseline visit

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