Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,081
- 试验地点
- 1
- 主要终点
- Patient characteristics in NVAF patients initiating a new AC-treatment
研究概览
简要总结
The present study will be conducted to assess the following research questions in real-life conditions in France:
What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment?
What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients?
What are the conditions of newly-initiated apixaban prescriptions in NVAF patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years
- •Diagnosed with non valvular atrial fibrillation (NVAF)
- •Prescribed with a newly initiated AC treatment (apixaban, other NOACs or VKAs). Newly initiated AC treatment is defined as any AC treatment initiated within the past 3 months, including day of enrolment
排除标准
- •Patients with atrial fibrillation (AF) due to reversible causes
- •Patients with a diagnosis of VAF. The term VAF is used to imply that AF is related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves
- •Patients participating in an ongoing clinical trial in AF
结局指标
主要结局
Patient characteristics in NVAF patients initiating a new AC-treatment
时间窗: Approximately 12 months
Patient's characteristics: age, gender, weight and height, BMI, dependence status
Disease characteristics in NVAF patients initiating a new AC-treatment
时间窗: Approximately 12 months
Disease characteristics: type of NVAF (permanent, paroxystic, persistent) ALD status (ALD: Affections de Longue Duree) for long term disease status (ALD 5, other ALDs specified, any ALD), disease duration
Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients
时间窗: Approximately 12 months
Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients
时间窗: Approximately 12 months
Comparing disease characteristics between apixaban and other NOACs in AC-naive patients
时间窗: Approximately 12 months
Comparing disease characteristics between apixaban and VKAs in AC-naive patients
时间窗: Approximately 12 months
Comorbidities in NVAF patients initiating a new AC-treatment
时间窗: Approximately 12 months
Comorbidities: congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding
Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients
时间窗: Approximately 12 months
Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients
时间窗: Approximately 12 months
Treatment history in NVAF patients initiating a new AC-treatment
时间窗: Approximately 12 months
Treatment history: Previous AC strategy (no treatment, apixaban, other NOAC, VKAs) , Duration with previous AC strategy and indication of previous AC treatment
Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients
时间窗: Approximately 12 months
Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients
时间窗: Approximately 12 months
次要结局
- Conditions of prescription of apixaban in NVAF patients(Approximately 12 months)
- Proportion of AC-naive patients(Approximately 12 months)
- Proportion of AC-experienced patients(Approximately 12 months)
- Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics(Approximately 12 months)
- Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)(Approximately 12 months)
- Distribution of reasons for choosing the newly initiated AC treatment(Approximately 12 months)
- Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)(Approximately 12 months)
- Distribution of reasons for initiating a new AC treatment(Approximately 12 months)
- Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment(Approximately 12 months)
- Mean number of daily doses for prescribed apixaban treatment according to patient characteristics(Approximately 12 months)