Prasugrel Re-load Strategies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01201772
First received: September 3, 2010
Last updated: January 17, 2013
Last verified: December 2011
Results First Received: January 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Intervention: Drug: Prasugrel

  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
Patients recuited at outpatient cardiology clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seventy-seven patients on maintenance prasugrel therapy were screened. Of these, 11 patients refused to participate in the study and one patient was excluded due to a positive pregnancy test. Thus, a total of 65 patients were randomized.

Reporting Groups
  Description
Prasugrel 10mg Prasugrel was administered as one 10 mg tablet
Prasugrel 30mg Prasugrel was administered as three 10 mg tablet
Prasugrel 60mg Prasugrel was administered as six 10 mg tablet

Participant Flow:   Overall Study
    Prasugrel 10mg     Prasugrel 30mg     Prasugrel 60mg  
STARTED     23     21     21  
COMPLETED     22     21     21  
NOT COMPLETED     1     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.
No text entered.

Reporting Groups
  Description
Prasugrel 10mg Prasugrel was administered as one 10 mg tablet
Prasugrel 30mg Prasugrel was administered as three 10 mg tablets
Prasugrel 60mg Prasugrel was administered as six 10 mg tablets
Total Total of all reporting groups

Baseline Measures
    Prasugrel 10mg     Prasugrel 30mg     Prasugrel 60mg     Total  
Number of Participants  
[units: participants]
  23     21     21     65  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     23     21     21     65  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 7     54  ± 7     52  ± 9     54  ± 7  
Gender  
[units: participants]
       
Female     7     8     3     18  
Male     16     13     18     47  
Region of Enrollment  
[units: participants]
       
United States     23     21     21     65  



  Outcome Measures

1.  Primary:   PRI Levels at 4 Hours   [ Time Frame: 4 hours after treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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.  


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


Publications of Results:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01201772     History of Changes
Other Study ID Numbers: UFJ 2010-49
Study First Received: September 3, 2010
Results First Received: January 9, 2013
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board