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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01743898
Other study ID # 12-1254
Secondary ID
Status Completed
Phase N/A
First received October 7, 2012
Last updated August 1, 2014
Start date October 2012
Est. completion date August 2014

Study information

Verified date August 2014
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2014
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 89 Years
Eligibility 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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
United States Carolina Point II Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

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