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.

Non-Valvular Atrial Fibrillation Clinical Trial

— BELANCE  

Official title:

BELgian ANtiCoagulation Survey for Elderly Patients With NVAF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722679
• Other study ID #: 21740
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: March 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 3, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation

Intervention

Drug:
• Non-VKA Oral Anticoagulants (NOAC)
Follow clinical practice.

Locations

Country	Name	City	State
Belgium	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age categories of patients and the geriatricians		Approximate 3 months for data collection
Primary	Gender of patients and the geriatricians		Approximate 3 months for data collection
Primary	Patient's weight		Approximate 3 months for data collection
Primary	Patient's kidney function range (normal, mild, moderate, severe)		Approximate 3 months for data collection
Primary	CHA2DS2-VASc range	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.	Approximate 3 months for data collection
Primary	Clinical Frailty Scale (CFS) range		Approximate 3 months for data collection
Primary	Timeframe of patient's diagnosis with NVAF		Approximate 3 months for data collection
Primary	Specification of HCP that initiated the elderly patient's NOAC treatment	HCP: HealthCare Professionals	Approximate 3 months for data collection
Primary	Specification of NOAC treatment		Approximately 3 months for data collection
Primary	Use of low-dose NOAC treatment (not related to an (S)AE)		Approximate 3 months for data collection
Primary	Confirmation of the use of anti-aggregants		Approximate 3 months for data collection
Primary	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)		Approximate 3 months for data collection
Primary	Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10		Approximate 3 months for data collection
Primary	Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10		Approximate 3 months for data collection