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A Prospective Pharmacodynamic Study of Dabigatran

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588327
First Posted: April 30, 2012
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose
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.

Condition
Blood Coagulation Tests

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Biospecimen Retention:   Samples Without DNA
Blood plasma

Enrollment: 65
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Experimental
Patient taking FDA approved dose of dabigatran
Control group
Person not taking any form of anticoagulation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients taking FDA-approved doses of dabigatran and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588327


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Emily Hawes, PharmD University of North Carolina, Chapel Hill
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01588327     History of Changes
Other Study ID Numbers: 11-1693
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: April 30, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants