Cited by 6,470Antiplatelet Therapy and Cardiovascular DiseasesAcute Myocardial Infarction ResearchCoronary Interventions and Diagnostics

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Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation

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The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators·2001·New England Journal of Medicine

DOI 10.1056/nejmoa010746

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Abstract

BACKGROUND: Despite current treatments, patients who have acute coronary syndromes without ST-segment elevation have high rates of major vascular events. We evaluated the efficacy and safety of the antiplatelet agent clopidogrel when given with aspirin in such patients. METHODS: We randomly assigned 12,562 patients who had presented within 24 hours after the onset of symptoms to receive clopidogrel (300 mg immediately, followed by 75 mg once daily) (6259 patients) or placebo (6303 patients) in addition to aspirin for 3 to 12 months. RESULTS: The first primary outcome--a composite of death from cardiovascular causes, nonfatal myocardial infarction, or stroke--occurred in 9.3 percent of the patients in the clopidogrel group and 11.4 percent of the patients in the placebo group (relative risk with clopidogrel as compared with placebo, 0.80; 95 percent confidence interval, 0.72 to 0.90; P<0.001). The second primary outcome--the first primary outcome or refractory ischemia--occurred in 16.5 percent of the patients in the clopidogrel group and 18.8 percent of the patients in the placebo group (relative risk, 0.86; 95 percent confidence interval, 0.79 to 0.94; P<0.001). The percentages of patients with in-hospital refractory or severe ischemia, heart failure, and revascularization procedures were also significantly lower with clopidogrel. There were significantly more patients with major bleeding in the clopidogrel group than in the placebo group (3.7 percent vs. 2.7 percent; relative risk, 1.38; P=0.001), but there were not significantly more patients with episodes of life-threatening bleeding (2.2 percent [corrected] vs. 1.8 percent; P=0.13) or hemorrhagic strokes (0.1 percent vs. 0.1 percent). CONCLUSIONS: The antiplatelet agent clopidogrel has beneficial effects in patients with acute coronary syndromes without ST-segment elevation. However, the risk of major bleeding is increased among patients treated with clopidogrel.

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Authors: The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators
Affiliations: Hamilton General Hospital (CA)
Corresponding author: The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2001-08-16
Volume: 345
Issue: 7
Pages: 494-502
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa010746
OpenAlex: W1553345686
Cited by: 6,470
References: 16
Citations by year: 2026: 63 · 2025: 99 · 2024: 77 · 2023: 110 · 2022: 121 · 2021: 163 · 2020: 168 · 2019: 202 · 2018: 216 · 2017: 229 · 2016: 265 · 2015: 325 · 2014: 319 · 2013: 397 · 2012: 395
FWCI: 178.22
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Repository of the Academy's Library (Library of the Hungarian Academy of Sciences) (acceptedVersion)
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: clopidogrel, aspirin, antiplatelet therapy, major bleeding, refractory ischemia, cardiovascular mortality, myocardial infarction, stroke, heart failure, revascularization
MeSH terms: Clopidogrel, Acute Disease, Aged, Aspirin, Cardiovascular Diseases, Drug Therapy, Combination, Electrocardiography, Female, Hemorrhage, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Risk Factors, Ticlopidine, Myocardial Ischemia

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Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation

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