Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 78,517
- 试验地点
- 1
- 主要终点
- Stroke or systemic embolism (SSE)
研究概览
简要总结
The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.
The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
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
- •Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and
- •Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)
排除标准
- •<18 years of age
- •<2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation
- •Valvular heart disease
- •Transient cause of NVAF
- •Venous thromboembolism
- •Hip or knee arthroplasty
- •Malignant cancer
- •Pregnancy
- •>1 oral anticoagulant prescribed (on index date)
研究组 & 干预措施
Rivaroxaban
Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Vitamin K antagonist (VKA)
Patients who initiated OAC treatment with VKA
干预措施: Vitamin K antagonist (VKA) (Drug)
结局指标
主要结局
Stroke or systemic embolism (SSE)
时间窗: Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding
时间窗: Retrospective analysis from January 1, 2011 to December 31, 2017
Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm
次要结局
- Ischemic stroke(Retrospective analysis from January 1, 2011 to December 31, 2017)
- Hemorrhagic stroke(Retrospective analysis from January 1, 2011 to December 31, 2017)
- Subtypes of major bleeding(Retrospective analysis from January 1, 2011 to December 31, 2017)
- Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)(Retrospective analysis from January 1, 2011 to December 31, 2017)
- Acute kidney injury(Retrospective analysis from January 1, 2011 to December 31, 2017)
- Renal impairment(Retrospective analysis from January 1, 2011 to December 31, 2017)