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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC. |
| |
| Physician | Geriatricians (hospital or office-based). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-VKA Oral Anticoagulants (NOAC) | Drug | Follow clinical practice. |
|
| 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 | |
| CHAâ‚‚DSâ‚‚-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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Belgium |
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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| 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 |