A Prospective Pharmacodynamic Study of Rivaroxaban

University of North Carolina (UNC)

Status: Completed

Conditions: Blood Clot

Treatments: Drug: Rivaroxaban; Other: no anticoagulation

Study type: Observational

Funder types: Other

Identifiers

NCT01743898

12-1254

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

65 participants in 2 patient groups

Experimental

Description:

Patient taking FDA approved dose of rivaroxaban

Treatment:

Drug: Rivaroxaban

Control Group

Description:

Patient not taking any form of anticoagulation

Treatment:

Other: no anticoagulation