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)

February 15, 2017 updated by: Bayer
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)

Study Overview

Study Type

Observational

Enrollment (Actual)

792

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Many Locations, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DOAC treated patients
Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC.
Treatment pattern following the summary of product characteristics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: At baseline visit
use of Haynes-Sackett test
At baseline visit
Satisfaction of treatment
Time Frame: At baseline visit
use of ACTS questionnaire
At baseline visit
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
At baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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