Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events

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dc.contributor.authorBhatt, D.L.
dc.contributor.authorFox, K.A.A.
dc.contributor.authorHacke, W.
dc.contributor.authorBerger, P.B.
dc.contributor.authorBlack, H.R.
dc.contributor.authorBoden, W.E.
dc.contributor.authorCacoub, P.
dc.contributor.authorCohen, E.A.
dc.contributor.authorCreager, M.A.
dc.contributor.authorEaston, J.D.
dc.contributor.authorFlather, M.D.
dc.contributor.authorHaffner, S.M.
dc.contributor.authorHamm, C.W.
dc.contributor.authorHankey, G.J.
dc.contributor.authorJohnston, S.C.
dc.contributor.authorMak, K.H.
dc.contributor.authorMas, J.L.
dc.contributor.authorMontalescot, G.
dc.contributor.authorPearson, T.A.
dc.contributor.authorSteg, P.G.
dc.contributor.authoret al.
dc.date.issued2006
dc.description.abstractBackground: Dual antiplatelet therapy with clopidogrel plus low-dose aspirin has not been studied in a broad population of patients at high risk for atherothrombotic events. Methods: We randomly assigned 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin and followed them for a median of 28 months. The primary efficacy end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes. Results: The rate of the primary efficacy end point was 6.8 percent with clopidogrel plus aspirin and 7.3 percent with placebo plus aspirin (relative risk, 0.93; 95 percent confidence interval, 0.83 to 1.05; P = 0.22). The respective rate of the principal secondary efficacy end point, which included hospitalizations for ischemic events, was 16.7 percent and 17.9 percent (relative risk, 0.92; 95 percent confidence interval, 0.86 to 0.995; P = 0.04), and the rate of severe bleeding was 1.7 percent and 1.3 percent (relative risk, 1.25; 95 percent confidence interval, 0.97 to 1.61 percent; P = 0.09). The rate of the primary end point among patients with multiple risk factors was 6.6 percent with clopidogrel and 5.5 percent with placebo (relative risk, 1.2; 95 percent confidence interval, 0.91 to 1.59; P = 0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (3.9 percent vs. 2.2 percent, P = 0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo (relative risk, 0.88; 95 percent confidence interval, 0.77 to 0.998; P = 0.046). Conclusions: In this trial, there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.
dc.description.statementofresponsibilityDeepak L. Bhatt, M.D., Keith A.A. Fox, M.B., Ch.B., Werner Hacke, M.D., Peter B. Berger, M.D., Henry R. Black, M.D., William E. Boden, M.D., Patrice Cacoub, M.D., Eric A. Cohen, M.D., Mark A. Creager, M.D., J. Donald Easton, M.D., Marcus D. Flather, M.D., Steven M. Haffner, M.D., Christian W. Hamm, M.D., Graeme J. Hankey, M.D., S. Claiborne Johnston, M.D., Koon-Hou Mak, M.D., Jean-Louis Mas, M.D., Gilles Montalescot, M.D., Ph.D., Thomas A. Pearson, M.D., P. Gabriel Steg, M.D., Steven R. Steinhubl, M.D., Michael A. Weber, M.D., Danielle M. Brennan, M.S., Liz Fabry-Ribaudo, M.S.N., R.N., Joan Booth, R.N., and Eric J. Topol, M.D., for the CHARISMA Investigators
dc.identifier.citationNew England Journal of Medicine, 2006; 354(16):1706-1717
dc.identifier.doi10.1056/NEJMoa060989
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.orcidFitridge, R. [0000-0001-6258-5997]
dc.identifier.orcidHorowitz, J. [0000-0001-6883-0703]
dc.identifier.urihttps://hdl.handle.net/2440/146086
dc.language.isoen
dc.publisherMassachusetts Medical Society
dc.rights© 2006 Massachusetts Medical Society. All rights reserved.
dc.source.urihttp://dx.doi.org/10.1056/nejmoa060989
dc.subjectcardiovascular disease; multiple risk factors; clopidogrel; low-dose aspirin; Dual antiplatelet therapy; atherothrombotic; high risk; medical trial
dc.titleClopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events
dc.typeJournal article
pubs.publication-statusPublished

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