临床试验/NCT02687867

NCT02687867已完成不适用

Real-world Comparative Effectiveness of Dabigatran Versus VKA

Bayer0 个研究点目标入组 56,039 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: 56,039
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 dabigatran versus Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial fibrillation (NVAF) 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

•Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) 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 (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 dabigatran use baseline period

排除标准

•Patients <18 years of age
•Patients with valvular Atrial fibrillation
•Pregnancy
•Malignant cancers
•Transient cause of Atrial fibrillation
•Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)
•Patients with major surgery defined as hip or knee replacement
•Prescriptions of Oral anticoagulants (OACs) {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

Dabigatran

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

干预措施: Dabigatran (Pradaxa) (Drug)

Vitamin K antagonist

Non-valvular atrial fibrillation patients who were initiated on VKA 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: Within 2 years of starting treatment

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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TCTR20221222001Faculty of Pharmacy, Silpakorn University2,134