A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)

This study has been completed.
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
Duke Clinical Research Institute
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00699998
First received: June 16, 2008
Last updated: March 21, 2013
Last verified: March 2013
Results First Received: March 21, 2013  
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: Acute Coronary Syndrome
Interventions: Drug: Clopidogrel
Drug: Prasugrel
Drug: Commercially-available Aspirin

  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: <75 Years of Age

Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.

Prasugrel: 75 Years of Age or Older

Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.

Clopidogrel: <75 Years of Age

Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.

Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study

Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Clopidogrel: 75 Years of Age or Older

Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.

Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.

Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.


Participant Flow:   Overall Study
    Prasugrel: <75 Years of Age     Prasugrel: 75 Years of Age or Older     Clopidogrel: <75 Years of Age     Clopidogrel: 75 Years of Age or Older  
STARTED     3620     1043     3623     1040  
Received at Least 1 Dose of Study Drug     3590     1033     3590     1027  
COMPLETED     3421     957     3417     958  
NOT COMPLETED     199     86     206     82  
Withdrawal by Subject                 194                 83                 202                 80  
Physician Decision                 3                 2                 1                 1  
Lost to Follow-up                 2                 1                 3                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke   [ Time Frame: Randomization through end of study (30-month visit) ]

2.  Secondary:   Percentage of Participants With a Composite Endpoint of CV Death and MI   [ Time Frame: Randomization through end of study (30-month visit) ]

3.  Secondary:   Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)   [ Time Frame: Randomization through end of study (30-month visit) ]

4.  Secondary:   Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke   [ Time Frame: Randomization through end of study (30-month visit) ]

5.  Secondary:   Platelet Aggregation Measures   [ Time Frame: Day 30 and 12 Months ]

6.  Secondary:   Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)   [ Time Frame: Day 30 and 6 Months ]

7.  Secondary:   Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)   [ Time Frame: Day 30 and Month 6 ]

8.  Secondary:   Genotyping Related to Drug Metabolism   [ Time Frame: Baseline ]

9.  Secondary:   Economic and Quality of Life Outcomes   [ Time Frame: Baseline and follow-up (24 months) ]

10.  Secondary:   Summary of All Deaths   [ Time Frame: Randomization through end of study (30-month visit) ]


  Serious Adverse Events


  Other Adverse Events


  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
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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: NCT00699998     History of Changes
Other Study ID Numbers: 11058, H7T-MC-TABY(b)
Study First Received: June 16, 2008
Results First Received: March 21, 2013
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration