A Prospective Pharmacodynamic Study of Rivaroxaban

Completed

Conditions studied: Blood Clot

In brief

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.

Key facts

Study ID

NCT01743898

Run by

University of North Carolina, Chapel Hill

People needed

65

Starts

2012-10-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-04

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Person taking therapeutic dose of Rivaroxaban

You may not qualify if…

• 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)

Where it is running

• Carolina Point II — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.