A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban
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
- 是
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
Suzanne J. Francart, PharmD, CPP
Pharm. D, CPP
University of North Carolina, Chapel Hill
