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临床试验/NCT01743898
NCT01743898已完成不适用

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年10月最近更新:
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
65
试验地点
1

研究概览

简要总结

The ability to explain bleeding or clotting complications in patients treated with rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding abnormal responses to rivaroxaban. 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 rivaroxaban and to determine which tests may be most clinically useful for monitoring rivaroxaban.

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

  • Person taking therapeutic dose of Rivaroxaban

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)

研究组 & 干预措施

Experimental

Patient taking FDA approved dose of rivaroxaban

干预措施: Rivaroxaban (Drug)

Control Group

Patient not taking any form of anticoagulation

干预措施: no anticoagulation (Other)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne J. Francart, PharmD, CPP

Pharm. D, CPP

University of North Carolina, Chapel Hill

研究点 (1)

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