Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,506
- 主要终点
- Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
研究概览
简要总结
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects with atrial fibrillation
干预措施: Dabigatran etexilate (Drug)
Subjects with atrial fibrillation
干预措施: Vitamin K antagonists (Drug)
结局指标
主要结局
Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
时间窗: 12 month (Visit 5)
Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.
次要结局
- Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.(6 month (visit 3))
- Number of Patients With the Reason for Definitive Treatment Discontinuation(Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment))