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A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00097591
First received: November 24, 2004
Last updated: August 25, 2010
Last verified: August 2010
History of Changes
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: Coronary Arteriosclerosis
Acute Coronary Syndromes
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
Acute Coronary Syndromes (ACS) includes subjects presenting with unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).

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 Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
Clopidogrel Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

Participant Flow:   Overall Study
    Prasugrel     Clopidogrel  
STARTED     6813 [1]   6795 [2]
COMPLETED     6403     6401  
NOT COMPLETED     410     394  
Withdrawal of consent                 342                 323  
Less than 6 months on study drug                 9                 7  
Unable to attend termination visit                 53                 51  
Lost to follow up                 6                 10  
Other                 0                 3  
[1] 7 subjects randomized but not analyzed due to an incomplete informed consent document
[2] 4 subjects randomized but not analyzed due to an incomplete informed consent document



  Baseline Characteristics
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Reporting Groups
  Description
Prasugrel Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
Clopidogrel Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
Total Total of all reporting groups

Baseline Measures
    Prasugrel     Clopidogrel     Total  
Number of Participants  
[units: participants]
 		  6813     6795     13608  
Age  
[units: years]
Mean ± Standard Deviation 		  60.9  ± 11.2     60.9  ± 11.4     60.9  ± 11.3  
Gender  
[units: participants]
 		     
Female     1705     1818     3523  
Male     5108     4977     10085  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Caucasian     6263     6274     12537  
African     205     187     392  
Hispanic     269     256     525  
Asian     60     64     124  
Other     16     14     30  
Region of Enrollment  
[units: participants]
 		     
North America     2164     2146     4310  
South America     270     264     534  
Europe     3436     3439     6875  
Middle East     606     613     1219  
Africa     204     200     404  
Pacifica     133     133     266  



  Outcome Measures
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1.  Primary:   Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization up to 15 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events   [ Time Frame: First dose of study drug up to 15 months (while at risk) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)   [ Time Frame: Randomization to 30 days; randomization to 90 days ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization to 30 days; randomization to 90 days ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events   [ Time Frame: Randomization up to 15 months ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization up to 15 months ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: Chief Medical Officer, Eli LIlly
ClinicalTrials.gov Identifier: NCT00097591     History of Changes
Other Study ID Numbers: 8695, H7T-MC-TAAL
Study First Received: November 24, 2004
Results First Received: April 19, 2010
Last Updated: August 25, 2010
Health Authority: United States: Food and Drug Administration