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临床试验/NCT01750788
NCT01750788已完成不适用

Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study

Bayer0 个研究点目标入组 2,297 人开始时间: 2013年1月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
2,297
主要终点
Adjudicated major bleeding events

研究概览

简要总结

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.

排除标准

  • 未提供

研究组 & 干预措施

Group 1

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

结局指标

主要结局

Adjudicated major bleeding events

时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Safety variables will be summarized using descriptive statistics based on adverse events collection

时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

All cause mortality

时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

次要结局

  • Healthcare resource(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Adverse events rates in the different AF risk factor categories(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Adjudicated symptomatic thromboembolic events(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
  • Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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