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A Prospective Pharmacodynamic Study of Dabigatran

NCT01588327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2012-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Blood Coagulation Tests

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Emily Hawes, PharmD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588327 on ClinicalTrials.gov