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临床试验/NCT02464488
NCT02464488已完成不适用

Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.

Hôpital Charles Foix2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
232
试验地点
2
主要终点
Pharmacologic parameters of new oral anticoagulants in elderly patients

研究概览

简要总结

Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.

详细描述

Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age 80 years or older
  • Under treatment with dabigatran, rivaroxaban or apixaban
  • For non-valvular atrial fibrillation

排除标准

  • Mechanical (non-biological) heart valve
  • Any severe condition leading to a short estimated life expectance (a few months)

结局指标

主要结局

Pharmacologic parameters of new oral anticoagulants in elderly patients

时间窗: 1 to 3 weeks

Estimated area under the curve (AUC) of each of the 3 drugs studied

次要结局

  • Hemorrhagic events(1 year)
  • Thromboembolic events(1 year)

研究者

发起方
Hôpital Charles Foix
申办方类型
Other
责任方
Sponsor

研究点 (2)

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