A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)
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ClinicalTrials.gov Identifier: NCT00699998 |
Recruitment Status
:
Completed
First Posted
: June 18, 2008
Results First Posted
: May 7, 2013
Last Update Posted
: May 7, 2013
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition: |
Acute Coronary Syndrome |
Interventions: |
Drug: Clopidogrel Drug: Prasugrel Drug: Commercially-available Aspirin |

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 | |
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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 | |
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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 |

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) ] |

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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