NCT01743898

A Prospective Pharmacodynamic Study of Rivaroxaban

A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Clot

Interventions

Type	Name	Description
DRUG	Rivaroxaban	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.
OTHER	no anticoagulation

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2014-08-01
• First posted: 2012-12-06
• Last updated: 2014-08-04

Locations

1 site across 1 country: United States