A Prospective Pharmacodynamic Study of Rivaroxaban

NCT01743898 | Completed

• 1 other identifier: 12-1254
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Clot

Study Arms (2)

Experimental

Patient taking FDA approved dose of rivaroxaban

Drug: Rivaroxaban

Control Group

Patient not taking any form of anticoagulation

Other: no anticoagulation

Interventions

Rivaroxaban DRUG

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.

Also known as: Xarelto

Experimental

no anticoagulation OTHER

Control Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Person taking therapeutic dose of Rivaroxaban

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Carolina Point II

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Emily Hawes, PharmD, BCPS, CPP

  Department of Family Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm. D, CPP

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: December 6, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 4, 2014

Record last verified: 2014-08

Locations

US (1)