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

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.

Study Overview

• Status: Completed
• Conditions: Blood Clot
• Intervention / Treatment: Drug: Rivaroxaban; Other: no anticoagulation

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Carolina Point II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients taking FDA-approved doses of rivaroxaban and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Patient taking FDA approved dose of rivaroxaban	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 Names: Xarelto
Control Group; Patient not taking any form of anticoagulation	Other: no anticoagulation

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Study Director: Emily Hawes, PharmD, BCPS, CPP, Department of Family Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 7, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: August 1, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 12-1254