A Prospective Pharmacodynamic Study of Dabigatran

Blood Coagulation Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588327
• Other study ID #: 11-1693
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: April 27, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill