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Prasugrel Re-load Strategies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201772
First Posted: September 15, 2010
Last Update Posted: January 18, 2013
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.
Information provided by (Responsible Party):
University of Florida
Results First Submitted: January 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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


  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
No text entered.


  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.


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
First Submitted: September 3, 2010
First Posted: September 15, 2010
Results First Submitted: January 9, 2013
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013