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A Prospective Pharmacodynamic Study of Rivaroxaban

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01743898
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Blood Clot Drug: Rivaroxaban Other: no anticoagulation

Study Design

Study Type : Observational
Estimated Enrollment : 65 participants
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
Study Start Date : October 2012
Primary Completion Date : March 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

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 Name: Xarelto
Control Group
Patient not taking any form of anticoagulation
Other: no anticoagulation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants