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

Bhatt, D. L., Fox, K. A. A., Hacke, W., Berger, P. B., Black, H. R., Boden, W. E., Cacoub, P., Cohen, E. A., Creager, M. A., Easton, J. D., Flather, M.D., Haffner, S. M., Hamm, C. W., Hankey, G. J., Johnston, S. C., Mak, K. H., Mas, J. L., Montalescot, G., Pearson, T. A., Steg, P. G., Steinhubl, S. R., Weber, M. A., Brennan, D. M., Fabry-Ribaudo, L., Booth, J., Topol, E. J., CHARISMA Investigators and Walker, P.J. (2006) Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. New England Journal of Medicine, 354 16: 1706-1717. doi:10.1056/NEJMoa060989

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Author Bhatt, D. L.
Fox, K. A. A.
Hacke, W.
Berger, P. B.
Black, H. R.
Boden, W. E.
Cacoub, P.
Cohen, E. A.
Creager, M. A.
Easton, J. D.
Flather, M.D.
Haffner, S. M.
Hamm, C. W.
Hankey, G. J.
Johnston, S. C.
Mak, K. H.
Mas, J. L.
Montalescot, G.
Pearson, T. A.
Steg, P. G.
Steinhubl, S. R.
Weber, M. A.
Brennan, D. M.
Fabry-Ribaudo, L.
Booth, J.
Topol, E. J.
CHARISMA Investigators
Walker, P.J.
Title Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2006-04-20
Sub-type Article (original research)
DOI 10.1056/NEJMoa060989
Open Access Status File (Publisher version)
Volume 354
Issue 16
Start page 1706
End page 1717
Total pages 12
Place of publication Boston, U.S.
Publisher Massachusetts Medical Society
Language eng
Subject 110201 Cardiology (incl. Cardiovascular Diseases)
11 Medical and Health Sciences
1102 Cardiovascular Medicine and Haematology
Formatted abstract
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.

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.

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. ( number, NCT00050817
Keyword Medicine, General & Internal
Acute Myocardial-infarction
St-segment Elevation
Antiplatelet Therapy
Controlled Trial
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 1437 times in Thomson Reuters Web of Science Article | Citations
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Created: Sat, 26 Jan 2008, 02:49:40 EST