A Prospective Pharmacodynamic Study of Dabigatran

University of North Carolina, Chapel Hill65 enrolled

Overview

The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. 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 dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Coagulation Tests

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: • Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days 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)

Data from ClinicalTrials.gov

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