Cited by 2,102Atrial Fibrillation Management and OutcomesAntiplatelet Therapy and Cardiovascular DiseasesAcute Ischemic Stroke Management

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Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation

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The ACTIVE Investigators·2009·New England Journal of Medicine

DOI 10.1056/nejmoa0901301

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Abstract

BACKGROUND: Vitamin K antagonists reduce the risk of stroke in patients with atrial fibrillation but are considered unsuitable in many patients, who usually receive aspirin instead. We investigated the hypothesis that the addition of clopidogrel to aspirin would reduce the risk of vascular events in patients with atrial fibrillation. METHODS: A total of 7554 patients with atrial fibrillation who had an increased risk of stroke and for whom vitamin K-antagonist therapy was unsuitable were randomly assigned to receive clopidogrel (75 mg) or placebo, once daily, in addition to aspirin. The primary outcome was the composite of stroke, myocardial infarction, non-central nervous system systemic embolism, or death from vascular causes. RESULTS: At a median of 3.6 years of follow-up, major vascular events had occurred in 832 patients receiving clopidogrel (6.8% per year) and in 924 patients receiving placebo (7.6% per year) (relative risk with clopidogrel, 0.89; 95% confidence interval [CI], 0.81 to 0.98; P=0.01). The difference was primarily due to a reduction in the rate of stroke with clopidogrel. Stroke occurred in 296 patients receiving clopidogrel (2.4% per year) and 408 patients receiving placebo (3.3% per year) (relative risk, 0.72; 95% CI, 0.62 to 0.83; P<0.001). Myocardial infarction occurred in 90 patients receiving clopidogrel (0.7% per year) and in 115 receiving placebo (0.9% per year) (relative risk, 0.78; 95% CI, 0.59 to 1.03; P=0.08). Major bleeding occurred in 251 patients receiving clopidogrel (2.0% per year) and in 162 patients receiving placebo (1.3% per year) (relative risk, 1.57; 95% CI, 1.29 to 1.92; P<0.001). CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable, the addition of clopidogrel to aspirin reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage. (ClinicalTrials.gov number, NCT00249873.)

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American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes31This document was approved by the American College of Cardiology Board of Trustees in November 2001.32When citing this document, the American College of Cardiology would appreciate the following citation format: Cannon CP, Battler A, Brindis RG, Cox JL, Ellis SG, Every NR, Flaherty JT, Harrington RA, Krumholz HM, Simoons ML, Van de Werf FJJ, Weintraub WS. ACC Key Elements and Data Definitions for Measuring the Clinical Management and Outcomes of Patients with Acute Coronrary Syndromes: a report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol 2001;38:2114–30.33This document is available on the World Wide Web site of the American College of Cardiology (www.acc.org). Reprints of this document may be purchased for $5.00 each by calling 1-800-253-4636 or by writing to the American College of Cardiology, Educational Services, 9111 Old Georgetown Road, Bethesda, Maryland 20814-1699. © 2001 by the American College of Cardiology
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BackgroundMethod
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Method
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Background
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Authors: The ACTIVE Investigators
Affiliations: Population Health Research Institute (CA)
Corresponding author: The ACTIVE Investigators
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2009-05-14
Volume: 360
Issue: 20
Pages: 2066-2078
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa0901301
OpenAlex: W2113089341
Cited by: 2,102
References: 25
Citations by year: 2026: 10 · 2025: 16 · 2024: 25 · 2023: 19 · 2022: 23 · 2021: 55 · 2020: 65 · 2019: 73 · 2018: 75 · 2017: 115 · 2016: 166 · 2015: 205 · 2014: 209 · 2013: 264 · 2012: 286
FWCI: 168.46
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
UWA Profiles and Research Repository (UWA) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
HAL (submittedVersion)
ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
Own your potential (DEAKIN) (submittedVersion)
Figshare (submittedVersion, cc-by)
University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion)
UnissResearch (Università degli Studi di Sassari) (submittedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
Keywords: clopidogrel, aspirin, atrial fibrillation, stroke prevention, antiplatelet therapy, vitamin K antagonists, myocardial infarction, major bleeding, vascular events, systemic embolism, anticoagulation alternatives, bleeding risk, stroke risk reduction, quality of life, cost-effectiveness
MeSH terms: Clopidogrel, Aged, Aspirin, Atrial Fibrillation, Double-Blind Method, Drug Therapy, Combination, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Risk, Ticlopidine, Vascular Diseases, Vitamin K, Incidence, Stroke

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Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation

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