跳至主要内容
临床试验/NCT01588327
NCT01588327已完成不适用

A Prospective Pharmacodynamic Study of Dabigatran Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Dabigatran

University of North Carolina, Chapel Hill0 个研究点目标入组 65 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65

研究概览

简要总结

The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days

排除标准

  • CrCl < 15 ml/min
  • Non-FDA approved dose based on calculated CrCl with most recent SCr
  • Age < 18 years
  • Inability to communicate in the English language
  • Decisionally-impaired individuals
  • Incarcerated
  • Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)

研究者

申办方类型
Other
责任方
Sponsor

相似试验