SAFETY AND EFFECTIVENESS EVALUATION OF PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION TREATED WITH OACS: COMPARISON BETWEEN NOACS AND WARFARIN (CER3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 73,989
- 试验地点
- 1
- 主要终点
- Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date
研究概览
简要总结
An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan
详细描述
An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan. This study will evaluate the risk of stroke/SE as well as the risk of bleeding in the real world settings in Japan in patients with NVAF who initiated any of OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date
时间窗: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date
时间窗: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date
时间窗: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
次要结局
- Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date(During the observation period of approximately 7 years)
- Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date(During the observation period of approximately 7 years)