check_circleStudy Completed

Non-Valvular Atrial Fibrillation

Bayer Identifier:

21740

ClinicalTrials.gov Identifier:

NCT04722679

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

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.

Key Participants Requirements

Sex

All

Age

75 - N/A
  • - Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
    - Elderly patients treated with a NOAC
    - Ambulatory patients visiting the geriatrician
  • - 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
103
Trial Dates
May 2021 - January 2022
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locationsmany locations, Belgium

Primary Outcome

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

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
N/A