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

History of Changes

Results First Received: March 21, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, 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

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Outcome Measures

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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) ]

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2. Secondary:

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

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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) ]

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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) ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

Genotyping Related to Drug Metabolism [ Time Frame: Baseline ]

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9. Secondary:

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

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10. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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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