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Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01852175
First received: May 8, 2013
Last updated: May 26, 2015
Last verified: August 2014
Results First Received: May 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Prasugrel
Drug: Ticagrelor

  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
Between December 2011 to June 2014 patients were screened at the outpatient cardiology clinics, UF Health, University of Florida, Jacksonville.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prasugrel Prasugrel 60mg loading dose and 10 mg maintenance dose
Ticagrelor Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Participant Flow:   Overall Study
    Prasugrel   Ticagrelor
STARTED   55   55 
COMPLETED   55   55 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
Prasugrel Prasugrel 60mg loading dose and 10 mg maintenance dose
Ticagrelor Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Total Total of all reporting groups

Baseline Measures
   Prasugrel   Ticagrelor   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   55   110 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   41   41   82 
>=65 years   14   14   28 
Gender 
[Units: Participants]
     
Female   19   26   45 
Male   36   29   65 
Region of Enrollment 
[Units: Participants]
     
United States   55   55   110 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)   [ Time Frame: 1 week ]

2.  Secondary:   Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)   [ Time Frame: 2 hours ]

3.  Secondary:   Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)   [ Time Frame: 24 hours ]


  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 J. Angiolillo, MD, PhD-Associate Professor of Medicine Director, Cardiovascular Research
Organization: University of Florida College of Medicine-Jacksonville
phone: +1-904-244-3005
e-mail: dominick.angiolillo@jax.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01852175     History of Changes
Other Study ID Numbers: UFJ 2011-143
Study First Received: May 8, 2013
Results First Received: May 4, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board