Trial record 1 of 1 for:    nct00910299
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Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)

This study has been terminated.
(Due to the low rate of primary endpoint events experienced in the study to date)
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00910299
First received: May 28, 2009
Last updated: May 8, 2012
Last verified: April 2012
Results First Received: April 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Artery Disease (CAD)
Interventions: Drug: Prasugrel
Drug: Clopidogrel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prasugrel One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Clopidogrel 75 mg oral daily maintenance dose up to 6 months.

Participant Flow:   Overall Study
    Prasugrel     Clopidogrel  
STARTED     212     211  
Received at Least 1 Dose of Study Drug     210     210  
COMPLETED     136     137 [1]
NOT COMPLETED     76     74  
Withdrawal by Subject                 16                 13  
Sponsor Decision                 58                 60  
Didn't receive any study drug                 2                 1  
[1] 1 participant died of sepsis while on study drug and was considered a “protocol completer.”



  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 One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Clopidogrel 75 mg oral daily maintenance dose up to 6 months.
Total Total of all reporting groups

Baseline Measures
    Prasugrel     Clopidogrel     Total  
Number of Participants  
[units: participants]
  212     211     423  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 8.3     66.3  ± 8.6     66.1  ± 8.4  
Gender  
[units: participants]
     
Female     59     57     116  
Male     153     154     307  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     1     1     2  
Black or African American     0     3     3  
White     211     207     418  
Region of Enrollment  
[units: participants]
     
United States     12     13     25  
Germany     200     198     398  



  Outcome Measures
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1.  Primary:   Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)   [ Time Frame: Baseline through 6 months ]

2.  Secondary:   Number of Participants With Stent Thrombosis (ST)   [ Time Frame: Baseline through 6 months ]

3.  Secondary:   Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)   [ Time Frame: Baseline through 6 months ]


  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
The study was terminated early, and no formal statistical time-to-event analysis was performed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00910299     History of Changes
Other Study ID Numbers: 12323, H7T-MC-TACW
Study First Received: May 28, 2009
Results First Received: April 10, 2012
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration