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A Prospective Pharmacodynamic Study of Rivaroxaban

This study is currently recruiting participants.
Verified December 2012 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Suzanne J. Francart, PharmD, CPP, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01743898
First received: October 7, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Blood Clot
 Drug: Rivaroxaban
Other: no anticoagulation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban

Resource links provided by NLM:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Estimated Enrollment: 65
Study Start Date: October 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Xarelto
Control Group
Patient not taking any form of anticoagulation
 Other: no anticoagulation

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743898

Contacts
Contact: Suzanne J Francart, Pharm. D, CPP 919 966 5149 sfrancar@unch.unc.edu

Locations
United States, North Carolina
Carolina Point II Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Cheryl Jeanneret         mailto:cheryl_jeanneret@med.unc.edu    
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Study Director: Emily Hawes, PharmD, BCPS, CPP Department of Family Medicine
  More Information

No publications provided

Responsible Party: Suzanne J. Francart, PharmD, CPP, Pharm. D, CPP, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01743898     History of Changes
Other Study ID Numbers: 12-1254
Study First Received: October 7, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013