Non-Valvular Atrial FibrillationBELANCENCT04722679
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.
An observational study of Non-Valvular Atrial Fibrillation, run by Bayer at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation
- What is being tested?
- Non-VKA Oral Anticoagulants (NOAC)
- Type of treatment
- Pill or oral medicine
- How many people
- 103 participants
- Where
- 1 siteBelgium
- Study dates
- 11 May 2021to 3 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
- Elderly patients treated with a NOAC
- Ambulatory patients visiting the geriatrician
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Non-Valvular Atrial Fibrillation
- Being tested
- Non-VKA Oral Anticoagulants (NOAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-VKA Oral Anticoagulants (NOAC)Drug
Follow clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC. Receives: Drug: Non-VKA Oral Anticoagulants (NOAC) | |
| Physician | Geriatricians (hospital or office-based). Receives: Drug: Non-VKA Oral Anticoagulants (NOAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age categories of patients and the geriatricians
Measured: Approximate 3 months for data collection
Gender of patients and the geriatricians
Measured: Approximate 3 months for data collection
Patient's weight
Measured: Approximate 3 months for data collection
Patient's kidney function range (normal, mild, moderate, severe)
Measured: 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.
Measured: Approximate 3 months for data collection
Clinical Frailty Scale (CFS) range
Measured: Approximate 3 months for data collection
Timeframe of patient's diagnosis with NVAF
Measured: Approximate 3 months for data collection
Specification of HCP that initiated the elderly patient's NOAC treatment
HCP: HealthCare Professionals
Measured: Approximate 3 months for data collection
Specification of NOAC treatment
Measured: Approximately 3 months for data collection
Use of low-dose NOAC treatment (not related to an (S)AE)
Measured: Approximate 3 months for data collection
Confirmation of the use of anti-aggregants
Measured: 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)
Measured: Approximate 3 months for data collection
Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10
Measured: Approximate 3 months for data collection
Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10
Measured: Approximate 3 months for data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start11 May 2021
- Primary completion31 Dec 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722679
- Sponsor's protocol ID
- 21740
- Acronym
- BELANCE
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BELgian ANtiCoagulation Survey for Elderly Patients With NVAF
- ClinicalTrials.gov ID
- NCT04722679
- Acronym / sponsor ID
- BELANCE / 21740
- Conditions
- Non-Valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Drug: Non-VKA Oral Anticoagulants (NOAC)Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC. |
| Physician | – | Drug: Non-VKA Oral Anticoagulants (NOAC)Geriatricians (hospital or office-based). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
- Elderly patients treated with a NOAC
- Ambulatory patients visiting the geriatrician
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-VKA Oral Anticoagulants (NOAC)Follow clinical practice. | Drug | Patient, Physician |
Primary outcome
Age categories of patients and the geriatricians
Time frame: Approximate 3 months for data collection
Gender of patients and the geriatricians
Time frame: Approximate 3 months for data collection
Patient's weight
Time frame: Approximate 3 months for data collection
Patient's kidney function range (normal, mild, moderate, severe)
Time frame: Approximate 3 months for data collection
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.
Clinical Frailty Scale (CFS) range
Time frame: Approximate 3 months for data collection
Timeframe of patient's diagnosis with NVAF
Time frame: Approximate 3 months for data collection
Specification of HCP that initiated the elderly patient's NOAC treatment
Time frame: Approximate 3 months for data collection
HCP: HealthCare Professionals
Specification of NOAC treatment
Time frame: Approximately 3 months for data collection
Use of low-dose NOAC treatment (not related to an (S)AE)
Time frame: Approximate 3 months for data collection
Confirmation of the use of anti-aggregants
Time frame: 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)
Time frame: Approximate 3 months for data collection
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
Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10
Time frame: Approximate 3 months for data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Valvular Atrial Fibrillation, run by Bayer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age categories of patients and the geriatricians (time frame: Approximate 3 months for data collection). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.