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
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
- 是
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
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