Clinical trial 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.
Official title: BELgian ANtiCoagulation Survey for Elderly Patients With NVAF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Valvular Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 103
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population of this study would be elderly patients population (defined as ≥ 75 years old) diagnosed with NVAF who are treated with a NOAC for this indication. In order to ensure the representativeness of the study population, 100-150 Belgian elderly patients will be taken into account.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Age categories of patients and the geriatricians
timeFrame: Approximate 3 months for data collection
measure: Gender of patients and the geriatricians
timeFrame: Approximate 3 months for data collection
measure: Patient's weight
timeFrame: Approximate 3 months for data collection
measure: Patient's kidney function range (normal, mild, moderate, severe)
timeFrame: Approximate 3 months for data collection
measure: CHA₂DS₂-VASc range
timeFrame: Approximate 3 months for data collection
measure: Clinical Frailty Scale (CFS) range
timeFrame: Approximate 3 months for data collection
measure: Timeframe of patient's diagnosis with NVAF
timeFrame: Approximate 3 months for data collection
measure: Specification of HCP that initiated the elderly patient's NOAC treatment
timeFrame: Approximate 3 months for data collection
measure: Specification of NOAC treatment
timeFrame: Approximately 3 months for data collection
measure: Use of low-dose NOAC treatment (not related to an (S)AE)
timeFrame: Approximate 3 months for data collection
measure: Confirmation of the use of anti-aggregants
timeFrame: Approximate 3 months for data collection
measure: 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)
timeFrame: Approximate 3 months for data collection
measure: Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10
timeFrame: Approximate 3 months for data collection
measure: Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10
timeFrame: Approximate 3 months for data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many Locations
Study officials:
References: