Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,008
- 试验地点
- 67
- 主要终点
- Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
研究概览
简要总结
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
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
- •The patient is willing and provides written informed consent to participate in this study
- •The patient is at least 18 years of age
- •The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)
- •The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016
排除标准
- •if the current participating patient participate in any clinical trial of a drug or device will be excluded
研究组 & 干预措施
patients with NVAF
patients with Non Valvular Atrial Fibrillation
干预措施: NOAC (Drug)
结局指标
主要结局
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
时间窗: Start of the first NOAC treatment
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.
Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
时间窗: Start of the first NOAC treatment
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
时间窗: Start of the first NOAC treatment
Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female)
Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
时间窗: Start of the first NOAC treatment
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
时间窗: Start of the first NOAC treatment
Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3)
次要结局
- Reason for Treatment Changes(Start of the first NOAC treatment)
- Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose(single visit (Day 1))
- Appropriateness of NOACs Prescription(single visit (Day 1))
- Mean Number of Visits to the Physician Per Year(1 year (data collected during single visit on day 1))
- Duration of First NOAC, All NOAC and Subsequent NOAC Treatment(Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.)
- Number of Patients With Previous Treatment With Vitamin K Antagonists(single visit (Day 1))
- Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC(single visit (Day 1))
- Duration of Previous VKA Treatment(Through the observational period with an average of 43.8 months, data collected during a single visit.)
- Patient's Knowledge About His Condition(single visit (Day 1))