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. (BELANCE)

BELgian ANtiCoagulation Survey for Elderly Patients With NVAF

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.

Study Overview

• Status: Completed
• Conditions: Non-Valvular Atrial Fibrillation
• Intervention / Treatment: Drug: Non-VKA Oral Anticoagulants (NOAC)

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC.	Drug: Non-VKA Oral Anticoagulants (NOAC); Follow clinical practice.
Physician; Geriatricians (hospital or office-based).	Drug: Non-VKA Oral Anticoagulants (NOAC); Follow clinical practice.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: 21740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No