Edoxaban Management in Diagnostic and Therapeutic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,197
- 主要终点
- Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure
研究概览
简要总结
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.
详细描述
Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.
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
- •Patients taking edoxaban for a therapeutic indication for edoxaban according to SMPC including NVAF, DVT or PE
- •Patients with a planned or unplanned diagnostic or therapeutic procedure
- •Written informed consent
- •Availability of patients for follow-up by telephone by the site
- •No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible)
排除标准
- 未提供
结局指标
主要结局
Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure
时间窗: within 30 days after a procedure
Categories: minor bleeding, all bleeding, and death from any cause
Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure
时间窗: within 30 days after a procedure
次要结局
- Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure(within 30 days after a procedure)