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OpenTrials
Completed

NCT Number: NCT01743898

A Prospective Pharmacodynamic Study of Rivaroxaban

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.

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Key information

Conditions

Blood Clot Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolina Point II

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Xarelto

no anticoagulation

Other

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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