- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (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
Status
Completed
Conditions
Intervention / Treatment
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
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Many Locations, Spain
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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 |
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DOAC treated patients
Patients diagnosed with Non-Valvular Atrial Fribilation at risk of stroke or systemic embolism treated in primary care centres with DOAC.
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Treatment pattern following the summary of product characteristics
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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
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sociodemographic data
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At baseline visit
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Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Concomitant treatments: relevant active substances
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Risk of thromboembolic event based on the CHADS2 score
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Risk of thromboembolic event based on the CHA2DS2-VASc score
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Risk of bleeding based on the HAS-BLED score
Time Frame: At baseline visit
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clinical characteristics
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At baseline visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to treatment
Time Frame: At baseline visit
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use of Haynes-Sackett test
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At baseline visit
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Satisfaction of treatment
Time Frame: At baseline visit
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use of ACTS questionnaire
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At baseline visit
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Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)
Time Frame: At baseline visit
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use IPT guideline
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At baseline visit
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17964
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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