Phase 3
N=9,326
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00699998 ↗Enrolled (actual)
9,326
Serious AEs
34.3%
Results posted
May 2013
Primary outcome: Primary: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke — 10.06; 24.64; 10.96; 24.13 percentage of participants with an event — p=0.210
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clopidogrel (Drug); Prasugrel (Drug); Commercially-available Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke |
10.06; 24.64; 10.96; 24.13 | 0.210 |
| SECONDARY Percentage of Participants With a Composite Endpoint of CV Death and MI |
9.61; 22.53; 10.21; 22.69 | 0.388 |
| SECONDARY Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) |
12.13; 26.27; 12.83; 25.67 | 0.353 |
| SECONDARY Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke |
10.61; 27.04; 11.12; 26.83 | 0.270 |
| SECONDARY Platelet Aggregation Measures |
93.280; 151.872; 193.489; 200.285; 94.529; 135.096 | <0.001 sig |
| SECONDARY Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) |
313.494; 1082.396; 319.345; 951.359; 253.434; 770.132 | 0.631 |
| SECONDARY Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) |
2.330; 2.441; 2.287; 2.226; 2.272; 1.593 | 0.727 |
| SECONDARY Genotyping Related to Drug Metabolism |
24.0; 25.0; 25.1; 21.8; 5.1; 3.6 | — |
| SECONDARY Economic and Quality of Life Outcomes |
67.8; 67.0; 73.6; 73.1; 75.1; 74.5 | 0.5 |
| SECONDARY Summary of All Deaths |
10; 21; 13; 23; 8; 4 | — |
Summary
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Eligibility Criteria
Key Inclusion Criteria
- Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
- Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
- Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event
Key Exclusion Criteria
- Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
- Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
- Previous or planned PCI or CABG as treatment for the index event
- PCI/CABG within previous 30 days
- ST-segment elevation myocardial infarction (STEMI) as the index event
- Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
- History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
- History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
- Hemodialysis or peritoneal dialysis
Data sourced from ClinicalTrials.gov (NCT00699998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.