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A Prospective Pharmacodynamic Study of Rivaroxaban

NCT01743898 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2014-08-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Emily Hawes, PharmD, BCPS, CPP · Department of Family Medicine

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-03-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01743898 on ClinicalTrials.gov