跳至主要内容
临床试验/NCT02422602
NCT02422602已完成不适用

Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2013年11月26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
入组人数
196
试验地点
1
主要终点
The occurence of serious adverse event

研究概览

简要总结

This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

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

  • All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history
  • Affiliate or beneficiary of a social security system.
  • Patient who formulated its "does not oppose" to participate in this research
  • Age higher than or equal to 18 years

排除标准

  • Opposition to participation
  • Patient don't understand french language
  • Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers)
  • Tutorship or curatoship
  • Law-protected patient
  • Pregnant women or breast-feeding

研究组 & 干预措施

Taking conventional charge

Active Comparator

No further information is given to the patient during the first and only contact with the nurse of the coordinator center. A time will be dedicated by the IDE to answer questions of the patient.

干预措施: Xarelto (Drug)

结局指标

主要结局

The occurence of serious adverse event

时间窗: 12 months

The occurence of serious adverse event

次要结局

  • The number ok hospitalization(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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