Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
研究概览
简要总结
A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale.
Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study).
- Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
- Evaluation of actual patient adherence to OACs
Secondary Study Objective(s)
- Evaluation of potential patient adherence to OACs
- Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
- Validation of new original 5-item Questionnaire
- Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)
详细描述
AF patients from ongoing PROFILE registry will be invited to visit the scientific center.
2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone contact is scheduled for each patient 1 year from the first visit to the scientific center (follow-up period).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
- •Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
- •Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK
排除标准
- •Patients with high bleeding risk, including patients with:
- •Congenital or acquired bleeding disorders
- •Uncontrolled resistant hypertension
- •Exacerbation of gastric and duodenal ulcer
- •Vascular retinopathy
- •Recent history of intracranial or intracerebral hemorrhage
- •Pathology of the brain and spinal cord vessels
- •Recent history of brain, spinal cord or eye surgery
- •History of bronchiectasis or pulmonary hemorrhage
- •A CHA2DS2-VASc score of 0 (OACs are not indicated)
- •Pregnancy, lactation
- •Planned surgery
- •Known hypersensitivity to ingredients of medications used in the study
结局指标
主要结局
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
时间窗: 6 months
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
时间窗: 1 year
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale. Out of 201 participants of the study 4 patients died and 197 patients completed the study.
次要结局
- Proportion of OACs Prescribed by Doctors According to Guidelines(Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
- Proportion of Potentially Adherent Patients(Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
- The Main Reasons for Refusing to Start NOAC Therapy(Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
- Reasons for Stopping Oral Anticoagulants (Data From Visit 1)(Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)))
- Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)(Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))