A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00059215
First received: April 21, 2003
Last updated: May 21, 2010
Last verified: May 2010
Results First Received: April 19, 2010  
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
Conditions: Cardiovascular Diseases
Heart Diseases
Interventions: Drug: Prasugrel (CS-747)
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 (CS-747) 40-mg LD/7.5 mg MD Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/10-mg MD Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/15-mg MD Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
Clopidogrel Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

Participant Flow:   Overall Study
    Prasugrel (CS-747) 40-mg LD/7.5 mg MD     Prasugrel (CS-747) 60-mg LD/10-mg MD     Prasugrel (CS-747) 60-mg LD/15-mg MD     Clopidogrel  
STARTED     200     200     251     254  
COMPLETED     187 [1]   186     236     239  
NOT COMPLETED     13     14     15     15  
Adverse Event                 5                 5                 9                 9  
Death                 0                 0                 3                 0  
Lost to Follow-up                 1                 2                 0                 0  
Withdrawal by Subject                 4                 4                 1                 3  
Protocol Violation                 1                 0                 1                 0  
Protocol entry criteria not met                 1                 1                 0                 2  
Physician Decision                 1                 2                 1                 1  
[1] One subject discontinued before receiving treatment and is not included in the evaluable set.



  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 (CS-747) 40 mg LD/7.5 mg MD Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60 mg LD/10 mg MD Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60-mg LD/15-mg MD Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
Clopidogrel Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
Total Total of all reporting groups

Baseline Measures
    Prasugrel (CS-747) 40 mg LD/7.5 mg MD     Prasugrel (CS-747) 60 mg LD/10 mg MD     Prasugrel (CS-747) 60-mg LD/15-mg MD     Clopidogrel     Total  
Number of Participants  
[units: participants]
  199     200     251     254     904  
Age, Customized  
[units: participants]
         
<=18 years     0     0     0     0     0  
>18 and <= 65 years     129     152     185     195     661  
> 65 years     70     48     66     59     243  
Age  
[units: years]
Mean ± Standard Deviation
  60.4  ± 8.72     58.7  ± 9.15     59.4  ± 8.97     58.4  ± 9.17     59.2  ± 9.03  
Gender  
[units: participants]
         
Female     47     49     53     59     208  
Male     152     151     198     195     696  
Race/Ethnicity, Customized  
[units: participants]
         
African descent     10     14     15     9     48  
Western Asian     3     3     1     3     10  
Caucasian     180     180     226     238     824  
East/Southeast Asian     1     1     1     0     3  
Hispanic     5     2     7     2     16  
Other     0     0     1     2     3  
Region of Enrollment  
[units: participants]
         
Canada     43     44     48     46     181  
United States     156     156     203     208     723  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events   [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

2.  Secondary:   Number of Participants With Major Adverse Cardiovascular Events (MACE)   [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

3.  Secondary:   Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding   [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]

4.  Secondary:   Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE   [ Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI) ]


  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:  
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


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00059215     History of Changes
Other Study ID Numbers: 7145, H7T-MC-TAAH
Study First Received: April 21, 2003
Results First Received: April 19, 2010
Last Updated: May 21, 2010
Health Authority: United States: Food and Drug Administration