Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention - German Non-interventional Study (ENCOURAGE-AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 666
- 试验地点
- 66
- 主要终点
- Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
研究概览
简要总结
This study is designed to gain real-world clinical data on the peri- and post-procedural usage of anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation (NVAF) undergoing successful percutaneous coronary intervention (PCI) treated with edoxaban.
详细描述
The study will assess real-world evidence data of anticoagulation and antiplatelet therapy in patients with NVAF undergoing PCI treated with edoxaban. The observation period will start 4 to 72 hours after removal of the guiding catheter of successful PCI in a hospital and ends 1 year after procedure. Follow-up telephone calls will take place approximately 1 month and 1 year after PCI. Real-world data of effectiveness of edoxaban and antiplatelet therapy, clinical events of interests, safety and quality of life (QoL) data of edoxaban will be collected.
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
- •≥ 18 years of age
- •Providing written informed consent (ICF) for participation in the study
- •NVAF treated with edoxaban
- •Successful PCI
- •No planned elective cardiac intervention for the whole duration of the study (up to 1 year)
- •Capability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
- •Availability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
- •Willingness of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
- •Not simultaneously participating in any interventional study
- •Life expectancy > 1 year
排除标准
- •Not applicable
研究组 & 干预措施
NVAF patients undergoing PCI
Patients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).
干预措施: Edoxaban (Drug)
结局指标
主要结局
Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
时间窗: Up to 1 year follow up after PCI
次要结局
- Number of Participants Reporting Clinical Events of Interest in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention(Up to 1 year follow up after PCI)
- EQ-5D-5L Assessment in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention(Up to 1 year follow up after PCI)
- Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention(Up to 1 year follow up after PCI)
- Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention(Up to 1 year follow up after PCI)