Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53,969
- 试验地点
- 1
- 主要终点
- The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
研究概览
简要总结
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
详细描述
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 year old non-valvular atrial fibrillation (NVAF) patients
- •Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
- •Patients with confirmed date of initiation of OACs
- •Patients with a minimum of 6 months of enrolment data prior to index date
- •Has an index date between 14th of March 2011 to 30 June, 2016
排除标准
- •Patients receiving two or more oral anti-coagulants at the same time at index date
- •Patients with prescriptions of index treatment in the 6 months prior to index date
- •Patients without enrolment period of at least six month in the database
研究组 & 干预措施
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
干预措施: warfarin (Drug)
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
干预措施: dabigatran (Drug)
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
干预措施: Apixaban (Drug)
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
干预措施: Edoxaban (Drug)
patients prescribed with Oral Anti-coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
时间窗: One year
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
次要结局
- The Number of Patients With Cardiac Tamponade and Pericardiocentesis.(One year)