A Prospective Pharmacodynamic Study of Rivaroxaban

Blood Clot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743898
• Other study ID #: 12-1254
• Status: Completed
• Phase: N/A
• First received: October 7, 2012
• Last updated: August 1, 2014
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Clot

Intervention

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

Locations

Country	Name	City	State
United States	Carolina Point II	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States,