Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

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. Identifier: NCT01852162
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Dabigatran
Drug: Placebo

  Participant Flow

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
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 
Adverse Event                1                0 
Withdrawal by Subject                3                1 

  Baseline Characteristics

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
Dabigatran Dabigatran 150mg tablets
Placebo Placebo tablets
Total Total of all reporting groups

Baseline Measures
   Dabigatran   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   16   30 
[Units: Years]
Mean (Standard Deviation)
 65  (8)   59  (9)   63  (9) 
[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

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

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
No text entered.

  More Information

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

Responsible Party: University of Florida Identifier: NCT01852162     History of Changes
Other Study ID Numbers: UFJ 2011-112
First Submitted: May 8, 2013
First Posted: May 13, 2013
Results First Submitted: February 3, 2015
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015