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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)

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ClinicalTrials.gov Identifier: NCT02470767
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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)

Condition or disease Intervention/treatment
Stroke Prevention and Control Atrial Fibrillation Drug: Direct Oral Anticoagulant (DOAC)

Study Design
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Study Type : Observational
Actual Enrollment : 792 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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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.
 Drug: Direct Oral Anticoagulant (DOAC)
Treatment pattern following the summary of product characteristics


Outcome Measures
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Primary Outcome Measures :
  1. Composite of demographic characteristics: age, gender and race [ Time Frame: At baseline visit ]
    sociodemographic data

  2. Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding [ Time Frame: At baseline visit ]
    clinical characteristics

  3. Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, [ Time Frame: At baseline visit ]
    clinical characteristics

  4. Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances [ Time Frame: At baseline visit ]
    clinical characteristics

  5. Concomitant treatments: relevant active substances [ Time Frame: At baseline visit ]
    clinical characteristics

  6. Risk of thromboembolic event based on the CHADS2 score [ Time Frame: At baseline visit ]
    clinical characteristics

  7. Risk of thromboembolic event based on the CHA2DS2-VASc score [ Time Frame: At baseline visit ]
    clinical characteristics

  8. Risk of bleeding based on the HAS-BLED score [ Time Frame: At baseline visit ]
    clinical characteristics


Secondary Outcome Measures :
  1. Adherence to treatment [ Time Frame: At baseline visit ]
    use of Haynes-Sackett test

  2. Satisfaction of treatment [ Time Frame: At baseline visit ]
    use of ACTS questionnaire

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470767


Locations
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Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02470767    
Other Study ID Numbers: 17964
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Anticoagulants