Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28,000
- 主要终点
- Rate of major bleeding events of patients with prior warfarin use
研究概览
简要总结
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).
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
- •Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
- •Individuals ≥18 years old on the index date
- •At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
- •At least 1 diagnosis of AF in the 12 months prior to index date
- •Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date
排除标准
- •Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date
研究组 & 干预措施
patients with prior warfarin therapy
NVAF patients with prior warfarin therapy (Warfarin treated)
干预措施: rivaroxaban (Drug)
patients naive to oral anticoagulant treatment
NVAF patients naïve to oral anticoagulant treatment (Naïve)
干预措施: apixaban (Drug)
patients naive to oral anticoagulant treatment
NVAF patients naïve to oral anticoagulant treatment (Naïve)
干预措施: dabigatran (Drug)
patients naive to oral anticoagulant treatment
NVAF patients naïve to oral anticoagulant treatment (Naïve)
干预措施: rivaroxaban (Drug)
patients with prior warfarin therapy
NVAF patients with prior warfarin therapy (Warfarin treated)
干预措施: apixaban (Drug)
patients with prior warfarin therapy
NVAF patients with prior warfarin therapy (Warfarin treated)
干预措施: dabigatran (Drug)
patients with prior warfarin therapy
NVAF patients with prior warfarin therapy (Warfarin treated)
干预措施: warfarin (Drug)
结局指标
主要结局
Rate of major bleeding events of patients with prior warfarin use
时间窗: up to 31 months
Discontinuation rate of patients who were naïve to oral anticoagulant
时间窗: up to 31 months
Rate of major bleeding events of patients who were naïve to oral anticoagulant
时间窗: up to 31 months
Discontinuation rate of patients with prior warfarin use
时间窗: up to 31 months
Rate of hospitalization due to major bleeding events of patients with warfarin use
时间窗: up to 31 months
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant
时间窗: up to 31 months
次要结局
- All-Cause Healthcare per patient per month (PPPM) cost(up to 31 months)
- AF-related Healthcare per patient per month (PPPM) cost(up to 31 months)
- Rate of AF-Related Early Hospitalization(up to 31 months)
- Rate of AF-Related Any Rehospitalization(up to 31 months)
- Rate of All-Cause Early Hospitalization(up to 31 months)
- Rate of All-Cause Any Rehospitalization(up to 31 months)
- Rate of All-Cause Hospitalization(up to 31 months)
- Rate of Atrial Fibrillation(AF)-Related Hospitalization(up to 31 months)