Blood Clot
Conditions
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.
Interventions
DRUGRivaroxaban
Patients will continue on their Rivaroxaban dose as previously prescribed by their individual physician. No dose adjustments will be made for the purpose of this study.
OTHERno anticoagulation
Sponsors
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Person taking therapeutic dose of Rivaroxaban
Exclusion criteria
* 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)
Countries
United States
Outcome results
None listed