A Prospective Pharmacodynamic Study of Rivaroxaban
- Registration Number
- NCT01743898
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Person taking therapeutic dose of Rivaroxaban
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Group no anticoagulation Patient not taking any form of anticoagulation Experimental Rivaroxaban Patient taking FDA approved dose of rivaroxaban
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Carolina Point II
🇺🇸Chapel Hill, North Carolina, United States