An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 247
- 主要终点
- Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
研究概览
简要总结
This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)
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 ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.
- •Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).
- •Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.
- •Patients who have given their informed consent in writing.
排除标准
- •Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.
- •Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.
- •Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .
研究组 & 干预措施
DOAC treated patients
Patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres with DOAC.
干预措施: Direct Oral Anticoagulant (DOAC) (Drug)
结局指标
主要结局
Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
时间窗: At baseline visit
clinical characteristics
Age
时间窗: At baseline visit
sociodemographic data
Race
时间窗: At baseline visit
sociodemographic data
Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
时间窗: At baseline visit
clinical characteristics
Risk of thromboembolic event based on the CHADS2 score
时间窗: At baseline visit
clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
时间窗: At baseline visit
sociodemographic data
Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
时间窗: At baseline visit
clinical characteristics
Concomitant treatments: therapy group of relevant active substances
时间窗: At baseline visit
clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify
Risk of bleeding based on the HAS-BLED score
时间窗: At baseline visit
clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly
Gender
时间窗: At baseline visit
sociodemographic data
Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
时间窗: At baseline visit
clinical characteristics
Risk of thromboembolic event based on the CHA2DS2-VASc score
时间窗: At baseline visit
clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
次要结局
- Adherence to treatment(At baseline visit)
- Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF.(At baseline visit)
- Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire(At baseline visit)
- Compliance with the criteria in therapeutic positioning report UT/V4/23122013(At baseline visit)