A Prospective Pharmacodynamic Study of Dabigatran
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.
Blood Coagulation Tests
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Prospective Pharmacodynamic Study of Dabigatran Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Dabigatran|
|Study Start Date:||October 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Patient taking FDA approved dose of dabigatran
Person not taking any form of anticoagulation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588327
|Principal Investigator:||Emily Hawes, PharmD||University of North Carolina, Chapel Hill|