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临床试验/NCT04722679
NCT04722679已完成不适用

BELgian ANtiCoagulation Survey for Elderly Patients With NVAF

Bayer1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2021年5月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
103
试验地点
1
主要终点
Specification of HCP that initiated the elderly patient's NOAC treatment

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
  • Elderly patients treated with a NOAC
  • Ambulatory patients visiting the geriatrician

排除标准

  • 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

研究组 & 干预措施

Patient

Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC.

干预措施: Non-VKA Oral Anticoagulants (NOAC) (Drug)

Physician

Geriatricians (hospital or office-based).

干预措施: Non-VKA Oral Anticoagulants (NOAC) (Drug)

结局指标

主要结局

Specification of HCP that initiated the elderly patient's NOAC treatment

时间窗: Approximate 3 months for data collection

HCP: HealthCare Professionals

Specification of NOAC treatment

时间窗: Approximately 3 months for data collection

Use of low-dose NOAC treatment (not related to an (S)AE)

时间窗: Approximate 3 months for data collection

Confirmation of the use of anti-aggregants

时间窗: Approximate 3 months for data collection

CHA₂DS₂-VASc range

时间窗: 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.

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)

时间窗: Approximate 3 months for data collection

Clinical Frailty Scale (CFS) range

时间窗: Approximate 3 months for data collection

Timeframe of patient's diagnosis with NVAF

时间窗: Approximate 3 months for data collection

Age categories of patients and the geriatricians

时间窗: Approximate 3 months for data collection

Gender of patients and the geriatricians

时间窗: Approximate 3 months for data collection

Patient's weight

时间窗: Approximate 3 months for data collection

Patient's kidney function range (normal, mild, moderate, severe)

时间窗: Approximate 3 months for data collection

Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10

时间窗: Approximate 3 months for data collection

Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10

时间窗: Approximate 3 months for data collection

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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