Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16,000
- 试验地点
- 1
- 主要终点
- Ischemic stroke
研究概览
简要总结
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
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
- •have to be adults (≥18 years of age)
- •newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug)
- •have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period)
- •have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and
- •have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period
排除标准
- •valvular AF (at least one inpatient diagnosis in the baseline period)
- •pregnancy (inpatient or outpatient diagnosis in the baseline period)
- •transient cause of AF (inpatient or outpatient diagnosis in the baseline period)
- •venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or
- •overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date)
- •have a pharmacy claim for an oral anticoagulation (OAC) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period
- •receive both warfarin and rivaroxaban 15 mg on the index date
- •have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period).
- •For the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. A sensitivity analysis, omitting this exclusion criterion, will be performed.
研究组 & 干预措施
Rivaroxaban
NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Warfarin
NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention
干预措施: Warfarin sodium (Drug)
结局指标
主要结局
Ischemic stroke
时间窗: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on the International Classification of Diseases, 9th- and 10th-revision, Clinical Modification (ICD-9/10-CM) diagnosis codes, Current Procedural Technology, 4th-revision (CPT-4) and Healthcare Common Procedure Coding System (HCPCS) procedure codes
Intracranial hemorrhage
时间窗: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Bleeding-related hospitalization
时间窗: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
次要结局
- Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis(Retrospecitive analysis from August 2011 to September 2017)
- Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage(Retrospective analysis from August 2011 to September 2017)