NCT01588327

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

April 26, 2012

Last Update Submit

April 27, 2012

Conditions

Blood Coagulation Tests

Study Arms (2)

Experimental

Patient taking FDA approved dose of dabigatran

Control group

Person not taking any form of anticoagulation.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients taking FDA-approved doses of dabigatran and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hawes EM, Deal AM, Funk-Adcock D, Gosselin R, Jeanneret C, Cook AM, Taylor JM, Whinna HC, Winkler AM, Moll S. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost. 2013 Aug;11(8):1493-502. doi: 10.1111/jth.12308.

    PMID: 23718677DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

Study Officials

  • Emily Hawes, PharmD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 30, 2012

Record last verified: 2012-04