跳至主要内容
临床试验/NCT03914053
NCT03914053已完成不适用

Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 3,387 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,387
试验地点
1
主要终点
time spent in the therapeutic range (TTR)

研究概览

简要总结

Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

详细描述

Despite the rise in prescriptions for direct oral anticoagulants, Vitamin K antagonists (VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

The management of VKA in France seems hardly comparable to that of the neighboring countries in front of:

  • A TTR estimated at 60%.
  • Majority management of anticoagulant treatments by general practitioners.
  • The weak development of clinics anticoagulants.
  • The takeoff of direct oral anticoagulant prescriptions.
  • Preponderance of fluindione prescriptions among the various oral anticoagulants.

It therefore seems interesting to study a cohort of French patients under VKA. Through the calculation of the TTR, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

研究设计

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

入排标准

接受健康志愿者

入选标准

  • Patient treated with VKA.
  • Realization of INR in one of the labs of the territory of LaboSud Oc biology between 1 September 2015 and 13 January 2016.

排除标准

  • Less than 3 INR during the data collection period (TTR calculation not possible).
  • Time greater than 56 days between two INRs (calculation of the invalid TTR).
  • Interrupted treatment (calculation of invalid TTR).
  • Lack of information about the patient

结局指标

主要结局

time spent in the therapeutic range (TTR)

时间窗: 1 day

calculating their time spent in the therapeutic range (TTR).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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