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Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization
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BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).
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“In addition to their initial events, such patients are at substantial risk for recurrent, potentially fatal events.”
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Metadata
- Authors
- Roe, M. T., Armstrong, P. W., Fox, K. A. A., White, H. D., Prabhakaran, D., Goodman, S. G., Cornel, J. H., Bhatt, D. L., Clemmensen, P., Martinez, F., Ardissino, D., Nicolau, J. C., Boden, W. E., Gurbel, P. A., Ruzyllo, W., Dalby, A. J., McGuire, D. K., Leiva-Pons, J. L., Parkhomenko, A., Gottlieb, S., Topacio, G. O., Hamm, C., Pavlides, G., Goudev, A. R., Oto, A., Tseng, C.-D., Merkely, B., Gasparovic, V., Corbalan, R., Cinteză, M., McLendon, R. C., Winters, K. J., Brown, E. B., Lokhnygina, Y., Aylward, P. E., Huber, K., Hochman, J. S., & Ohman, E. M.
- Affiliations
- Duke Medical Center (US)
- University of Alberta (CA)
- Duke University (US)
- St. Michael's Hospital (CA)
- Brigham and Women's Hospital (US)
- University of Copenhagen (DK)
- National Taiwan University (TW)
- Eli Lilly (United States) (US)
- Flinders University (AU)
- ORCID
- Roe, Matthew T.
- Armstrong, Paul W.
- Fox, Keith A.A.
- White, Harvey D.
- Prabhakaran, Dorairaj
- Goodman, Shaun G.
- Cornel, Jan H.
- Bhatt, Deepak L.
- Clemmensen, Peter
- Ardissino, Diego
- Boden, William E.
- Gurbel, Paul A.
- McGuire, Darren K.
- Leiva-Pons, Jose L.
- Parkhomenko, Alexander
- Gottlieb, Shmuel
- Hamm, Christian
- Goudev, Assen R.
- Oto, Ali
- Aylward, Philip E.
- Huber, Kurt
- Hochman, Judith S.
- Ohman, E. Magnus
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-10-04
- Volume
- 367
- Issue
- 14
- Pages
- 1297-1309
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2109577952
- Cited by
- 874
- References
- 18
- Citations by year
- 2026: 16 · 2025: 24 · 2024: 14 · 2023: 31 · 2022: 43 · 2021: 49 · 2020: 58 · 2019: 53 · 2018: 70 · 2017: 92 · 2016: 71 · 2015: 91 · 2014: 114 · 2013: 124 · 2012: 20
- FWCI
- 71.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Scientific Electronic Library Online (São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico) (publishedVersion)
- Trakya University's Institutional Open Access System (Trakya University) (submittedVersion, other-oa)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Hacettepe University Institutional Repository (hacettepe.edu.tr) (submittedVersion, other-oa)
- ORBi (University of Liège) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Radboud Repository (Radboud University) (submittedVersion)
- Funders
- Abbott Laboratories
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- Amylin Pharmaceuticals
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Helsinn
- Boston Scientific Corporation
- Boston VA Research Institute
- Regeneron Pharmaceuticals
- Amarin Corporation
- Medicines Company
- Regado Biosciences
- Eisai
- Astellas Pharma
- Servier
- Genentech
- Janssen Pharmaceuticals
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Coronary Interventions and Diagnostics
- Keywords
- prasugrel, clopidogrel, acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina, platelet aggregation inhibition, antiplatelet therapy, bleeding risk, heart failure, cardiovascular mortality, stroke, elderly patients
- MeSH terms
- Prasugrel Hydrochloride, Clopidogrel, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction, Piperazines, Platelet Aggregation Inhibitors, Thiophenes, Ticlopidine, Stroke, Kaplan-Meier Estimate, Acute Coronary Syndrome, Purinergic P2 Receptor Antagonists
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