临床试验/NCT02485873

NCT02485873已完成不适用

REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation

Bayer0 个研究点目标入组 8,607 人开始时间: 2015年5月最近更新: 2015年11月11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: 8,607
主要终点: Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI)

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 rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) 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

•Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window
•Diagnosis of NVAF on start date of study or anytime during 365 days before this date
•Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)
•Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.

排除标准

•Patients with valvular AF
•Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date
•Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period
•Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort

研究组 & 干预措施

Rivaroxaban

Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention

干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Vitamin K antagonists (VKA)

NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention

干预措施: Vitamin K antagonists (Drug)

结局指标

主要结局

Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI)

时间窗: Within 1 year after treatment start

Composite cardiovascular endpoint

次要结局

Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage(Within 1 year after treatment start)
Time to first occurrence of IS(Within 1 year after treatment start)
Time to first occurrence of TIA(Within 1 year after treatment start)
Time to first occurrence of IH(Within 1 year after treatment start)
Time to first occurrence of MI(Within 1 year after treatment start)
Incidence density in study population of IS(Within 1 year after treatment start)
Incidence density in study population of TIA(Within 1 year after treatment start)
Incidence density in study population of IH(Within 1 year after treatment start)
Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage(Within 1 year after treatment start)
Incidence density in study population of MI(Within 1 year after treatment start)
Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI(Within 1 year after treatment start)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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