A Prospective Pharmacodynamic Study of Rivaroxaban

This study has been completed.
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: August 1, 2014
Last verified: August 2014
  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:


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

Estimated Enrollment: 65
Study Start Date: October 2012
Study Completion Date: August 2014
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743898

Locations
United States, North Carolina
Carolina Point II
Chapel Hill, North Carolina, United States, 27514
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: August 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014