Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01852214
First received: May 8, 2013
Last updated: August 22, 2016
Last verified: June 2016
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Coronary Artery Disease
Interventions: Drug: Prasugrel
Drug: Ticagrelor

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 2013 and July 2015, a total of 61 subjects agreed to participate in the study; 11 subjects were excluded and thus a total of 50 subjects were randomized (prasugrel first n=26; ticagrelor first n=24).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11 subjects were excluded before randomization: withdrawn of consent (n=4), screen failure (n=4), unable to draw blood (n=3).

Reporting Groups
  Description
Prasugrel First, Then Ticagrelor

Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose

Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose

Ticagrelor First, Then Prasugrel

Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose

Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose


Participant Flow for 3 periods

Period 1:   Period 1
    Prasugrel First, Then Ticagrelor   Ticagrelor First, Then Prasugrel
STARTED   26   24 
COMPLETED   25   21 
NOT COMPLETED   1   3 
Adverse Event                1                2 
Withdrawal by Subject                0                1 

Period 2:   Washout Period
    Prasugrel First, Then Ticagrelor   Ticagrelor First, Then Prasugrel
STARTED   25   21 
COMPLETED   25   20 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 3:   Period 2
    Prasugrel First, Then Ticagrelor   Ticagrelor First, Then Prasugrel
STARTED   25   20 
COMPLETED   25   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide 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.
All analyses of platelet function were conducted on the pharmacodynamic population, which was defined as all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point (n=46)

Reporting Groups
  Description
Overall Population Subjects with type 2 diabetes mellitus and coronary artery disease

Baseline Measures
   Overall Population 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (8) 
Gender 
[Units: Participants]
 
Female   13 
Male   33 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   16 
White   30 
More than one race   0 
Unknown or Not Reported   0 
Type of diabetes 
[Units: Participants]
 
Insulin-dependent   26 
Non-insulin-dependent   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   P2Y12 Reaction Units   [ Time Frame: 1 week ]

2.  Secondary:   P2Y12 Reaction Units   [ Time Frame: 2 hours ]

3.  Secondary:   Platelet Reactivity Index   [ Time Frame: 1 week ]

4.  Secondary:   Platelet Reactivity Index   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dominick J. Angiolillo, MD, PhD
Organization: University of Florida College of Medicine-Jacksonville
phone: +1-904-244-3933
e-mail: dominick.angiolillo@jax.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01852214     History of Changes
Other Study ID Numbers: UFJ 2011-184
Study First Received: May 8, 2013
Results First Received: April 15, 2016
Last Updated: August 22, 2016