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临床试验/NCT03462446
NCT03462446已完成不适用

Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists

Bayer0 个研究点目标入组 249 人开始时间: 2015年6月1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
249
主要终点
Presence of stroke

研究概览

简要总结

The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.

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

入选标准

  • Older than 18 years
  • Diagnosis of non-valvular AF (ICD code 427.31)
  • Pharmacological treatment with VKAs or rivaroxaban following diagnosis

排除标准

  • 未提供

研究组 & 干预措施

Treatment group with Rivaroxaban

Patients treated with Rivaroxaban

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

Control group with VKAs

Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%).

干预措施: Vitamin K antagonists (VKAs) (Drug)

结局指标

主要结局

Presence of stroke

时间窗: 12 months

Presence of stroke prior and subsequent to treatment

Active substance received

时间窗: 12 months

Rivaroxaban or VKAs (Acenocoumarol and Warfarin)

Time in therapeutic range (TTR) values in the last 6 months

时间窗: 6 months

次要结局

  • Frequency of the prescribed treatment (in hours)(12 months)
  • Date of stroke(12 months)
  • Duration of treatment (in days)(12 months)
  • Type of stroke(12 months)
  • Dose of the prescribed treatment(12 months)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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