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Completed

NCT Number: NCT02559232

An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers

This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prevention and Control Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Spain

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 non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.
  • Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).
  • Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.
  • 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 non-valvular atrial fibrillation with a direct oral anticoagulant .

Treatment and study plan

Direct Oral Anticoagulant (DOAC)

Drug

Treatment pattern following the summary of product characteristics

Primary outcomes

  1. Age

    Time frame: At baseline visit

    sociodemographic data

  2. Gender

    Time frame: At baseline visit

    sociodemographic data

  3. Race

    Time frame: At baseline visit

    sociodemographic data

  4. Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding

    Time frame: At baseline visit

    sociodemographic data

  5. Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia

    Time frame: At baseline visit

    clinical characteristics

  6. Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances

    Time frame: At baseline visit

    clinical characteristics

  7. Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances

    Time frame: At baseline visit

    clinical characteristics

  8. Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances

    Time frame: At baseline visit

    clinical characteristics

  9. Concomitant treatments: therapy group of relevant active substances

    Time frame: At baseline visit

    clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify

  10. Risk of thromboembolic event based on the CHADS2 score

    Time frame: At baseline visit

    clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke

  11. Risk of thromboembolic event based on the CHA2DS2-VASc score

    Time frame: At baseline visit

    clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category

  12. Risk of bleeding based on the HAS-BLED score

    Time frame: At baseline visit

    clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly

Secondary outcomes

  1. Adherence to treatment

    Time frame: At baseline visit

    use of Haynes-Sackett test

  2. Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire

    Time frame: At baseline visit

  3. Compliance with the criteria in therapeutic positioning report UT/V4/23122013

    Time frame: At baseline visit

    In some Spanish regions it is mandatory to accomplish the conditions of the national guideline UT/V4/23122013 regarding the use of direct oral anticoagulant. In that guideline the characteristics of patients candidates to direct oral anticoagulant are explained.

  4. Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF.

    Time frame: At baseline visit

    Healthcare resources

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers

Acronym: BRONCE-AP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 24, 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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