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NCT Number: NCT04722679

A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.

Atrial fibrillation is a heart condition that causes an abnormal and fast heart rate. For people with non-valvular atrial fibrillation (NVAF), this is caused by problems such as high blood pressure and diabetes. NVAF happens more often in elderly people and can lead to stroke, heart failure, and death. Doctors are currently able to give patients a type of treatment called an anticoagulant. Anticoagulants work by making the blood thinner. They are thought to help reduce the risk of stroke and death caused by NVAF. In this study, researchers wanted to learn more about what elderly people think of taking anticoagulants that do not have any vitamin K in them. These are called non-VKA oral anticoagulants (NOACs).

This study will include up to about 150 Belgian men and women aged 75 years and over who have NVAF and have been treated with NOACs. The study will also include about 10 doctors who have treated these patients.

In this study, there will be no required tests or visits. Instead, patients will answer a paper questionnaire about their use of NOACs. The researchers will ask the doctors questions about how they treat their patients using NOACs. The main types of questions the researchers will focus on are:

* The patient characteristics of the elderly with NVAF who are treated with NOACs * The level of fear of the elderly about bleeding while using a blood thinner and the fear of stroke/thrombosis. * The geriatrician's thoughts about using NOACs to treat NVAF in elderly patients * Those patient characteristics geriatrician's find most important when deciding on the anticoagulation treatment in the elderly patients.

The information from this study will be collected between February and April 2021. But, the whole study will take about 6 months to finish and is expected to end in July 2021.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
  • Elderly patients treated with a NOAC
  • Ambulatory patients visiting the geriatrician

Exclusion criteria

  • Contra-indications according to the local marketing authorization
  • Patients suffering from dementia who are, according to the geriatrician's opinion, not able to understand and answer the questions
  • Hospitalized patients

Treatment and study plan

Non-VKA Oral Anticoagulants (NOAC)

Drug

Follow clinical practice.

Primary outcomes

  1. Age categories of patients and the geriatricians

    Time frame: Approximate 3 months for data collection

  2. Gender of patients and the geriatricians

    Time frame: Approximate 3 months for data collection

  3. Patient's weight

    Time frame: Approximate 3 months for data collection

  4. Patient's kidney function range (normal, mild, moderate, severe)

    Time frame: Approximate 3 months for data collection

  5. CHA₂DS₂-VASc range

    Time frame: Approximate 3 months for data collection

    CHA2DS2-VASc score is a clinical prediction rule for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke.

  6. Clinical Frailty Scale (CFS) range

    Time frame: Approximate 3 months for data collection

  7. Timeframe of patient's diagnosis with NVAF

    Time frame: Approximate 3 months for data collection

  8. Specification of HCP that initiated the elderly patient's NOAC treatment

    Time frame: Approximate 3 months for data collection

    HCP: HealthCare Professionals

  9. Specification of NOAC treatment

    Time frame: Approximately 3 months for data collection

  10. Use of low-dose NOAC treatment (not related to an (S)AE)

    Time frame: Approximate 3 months for data collection

  11. Confirmation of the use of anti-aggregants

    Time frame: Approximate 3 months for data collection

  12. Level of agreement with various statements regarding the use of NOACs in general, using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)

    Time frame: Approximate 3 months for data collection

  13. Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10

    Time frame: Approximate 3 months for data collection

  14. Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10

    Time frame: Approximate 3 months for data collection

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BELgian ANtiCoagulation Survey for Elderly Patients With NVAF

Acronym: BELANCE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 25, 2021
Registry last updated
Mar 22, 2022

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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