Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01852162
First received: May 8, 2013
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Dabigatran
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a prospective, randomized, double-blind, placebo-controlled PD study conducted in patients with CAD on maintenance DAPT with aspirin and clopidogrel. Patients were screened at the Division of Cardiology of the University Of Florida College Of Medicine - Jacksonville from February 2012 to December 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dabigatran Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
Placebo Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.

Participant Flow:   Overall Study
    Dabigatran     Placebo  
STARTED     18     17  
COMPLETED     14     16  
NOT COMPLETED     4     1  
Adverse Event                 1                 0  
Withdrawal by Subject                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients were considered for analysis of the PD end points if they completed both visits and had a compliance >80% to study drug, clopidogrel and aspirin. All patients who received any dose of study medication were considered for analysis of safety and any other adverse events.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg tablets
Placebo Placebo tablets
Total Total of all reporting groups

Baseline Measures
    Dabigatran     Placebo     Total  
Number of Participants  
[units: participants]
  14     16     30  
Age  
[units: years]
Mean (Standard Deviation)
  65  (8)     59  (9)     63  (9)  
Gender  
[units: participants]
     
Female     3     3     6  
Male     11     13     24  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     4     8  
White     10     11     21  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     14     16     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   TRAP-induced Platelet Aggregation   [ Time Frame: 1 week ]

2.  Secondary:   Platelet Reactivity Measured by LTA   [ Time Frame: 1-week ]

3.  Secondary:   Platelet Reactivity Measured by Multiple Electrode Aggregometry.   [ Time Frame: 1-week ]

4.  Secondary:   Clot Kinetic: Thrombin Activity   [ Time Frame: 1-week ]

5.  Secondary:   Clot Kinetic: Clot Stength   [ Time Frame: 1-week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dominick Angiolillo, MD, PhD
Organization: University of Florida
phone: 904-244-3933
e-mail: dominick.angiolillo@jax.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01852162     History of Changes
Other Study ID Numbers: UFJ 2011-112
Study First Received: May 8, 2013
Results First Received: February 3, 2015
Last Updated: March 10, 2015
Health Authority: United States: Institutional Review Board