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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
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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 (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 
Overall Participants Analyzed 
[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
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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



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00059215     History of Changes
Other Study ID Numbers: 7145
H7T-MC-TAAH ( Other Identifier: Eli Lilly and Company )
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