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OpenTrials
Completed

NCT Number: 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

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)

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Direct Oral Anticoagulant (DOAC)

Drug

Treatment pattern following the summary of product characteristics

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: SILVER-AP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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