Trial Condition(s):
Non-valvular Atrial Fibrillation
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)
Bayer Identifier:
21740
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations many locations many locations, Belgium | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
BELgian ANtiCoagulation survey for Elderly patients with NVAF
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Age categories of patients and the geriatriciansTimeframe: Approximate 3 months for data collection
- Gender of patients and the geriatriciansTimeframe: Approximate 3 months for data collection
- Patient’s weightTimeframe: Approximate 3 months for data collection
- Patient’s kidney function range (normal, mild, moderate, severe)Timeframe: Approximate 3 months for data collection
- CHA₂DS₂-VASc rangeCHA2DS2-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.Timeframe: Approximate 3 months for data collection
- Clinical Frailty Scale (CFS) rangeTimeframe: Approximate 3 months for data collection
- Timeframe of patient’s diagnosis with NVAFTimeframe: Approximate 3 months for data collection
- Specification of HCP that initiated the elderly patient’s NOAC treatmentHCP: HealthCare ProfessionalsTimeframe: Approximate 3 months for data collection
- Specification of NOAC treatmentTimeframe: Approximately 3 months for data collection
- Use of low-dose NOAC treatment (not related to an (S)AE)Timeframe: Approximate 3 months for data collection
- Confirmation of the use of anti-aggregantsTimeframe: 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)Timeframe: Approximate 3 months for data collection
- Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 – 10Timeframe: Approximate 3 months for data collection
- Indication of fear of contracting a stroke or thrombosis on a scale from 0 – 10Timeframe: Approximate 3 months for data collection
Additional Information
Not Available
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