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临床试验/NCT01006486
NCT01006486已完成4 期

Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
280
试验地点
2
主要终点
Time in therapeutic range

研究概览

简要总结

A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.

详细描述

A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

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

  • Outpatients
  • Chagas and non-Chagas disease patients
  • Any indication for chronic treatment with warfarin
  • Anticoagulation for at least 30 days.

排除标准

  • Refusal to participate in the study;
  • Use of phenprocoumon;
  • Expectation of treatment lower than 1 year;
  • Difficulties to attend medical visits;
  • Participation in other prospective clinical study involving anticoagulation care during the study period.

结局指标

主要结局

Time in therapeutic range

时间窗: 1 year

次要结局

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

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Luiz Pinho Ribeiro

Professor Antonio Luiz Pinho Ribeiro

Federal University of Minas Gerais

研究点 (2)

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