临床试验/NCT02687854

NCT02687854已完成不适用

Real-world Comparative Effectiveness of Apixaban Versus VKA

Bayer0 个研究点目标入组 18,591 人开始时间: 2016年2月12日最近更新: 2017年4月5日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 18,591
主要终点: Incidence of Hospitalization Events (composite endpoint)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.

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

•NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
•Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
•CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score ≥2 during the 180 days prior to index apixaban use baseline period

排除标准

•Patients <18 years of age
•Patients with valvular AF (Atrial fibrillation)
•Pregnancy
•Malignant cancers
•Transient cause of AF
•Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))
•Patients with major surgery defined as hip or knee replacement
•Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
•Prescription of more than one OAC on the index date
•Patient with any of the events defined in the composite endpoint

研究组 & 干预措施

Apixaban

Non-valvular atrial fibrillation patients who were initiated on apixaban for stroke prevention

干预措施: Apixaban (Drug)

Vitamin K antagonist

Non-valvular atrial fibrillation patients who were initiated on Vitamin K antagonist for stroke prevention

干预措施: Vitamin K antagonist (Drug)

结局指标

主要结局

Incidence of Hospitalization Events (composite endpoint)

时间窗: Up to 2 years

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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