Cited by 1,952Atrial Fibrillation Management and OutcomesAntiplatelet Therapy and Cardiovascular DiseasesAcute Ischemic Stroke Management

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Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial

‡·2006·The Lancet

DOI 10.1016/s0140-6736(06)68845-4

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Abstract

Background Oral anticoagulation therapy reduces risk of vascular events in patients with atrial fibrillation. However, long-term monitoring is necessary and many patients cannot achieve optimum anticoagulation. We assessed whether clopidogrel plus aspirin was non-inferior to oral anticoagulation therapy for prevention of vascular events.Methods Patients were enrolled if they had atrial fibrillation plus one or more risk factor for stroke, and were randomly allocated to receive oral anticoagulation therapy (target international normalised ratio of 2.0-3.0; n=3371) or clopidogrel (75 mg per day) plus aspirin (75-100 mg per day recommended; n=3335). Outcome events were adjudicated by a blinded committee. Primary outcome was first occurrence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death. Analyses were by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00243178.Results The study was stopped early because of clear evidence of superiority of oral anticoagulation therapy. There were 165 primary events in patients on oral anticoagulation therapy (annual risk 3.93%) and 234 in those on clopidogrel plus aspirin (annual risk 5.60%; relative risk 1.44 (1.18-1.76; p=0.0003). Patients on oral anticoagulation therapy who were already receiving this treatment at study entry had a trend towards a greater reduction in vascular events (relative risk 1.50, 95% CI 1.19-1.89) and a significantly (p=0.03 for interaction) lower risk of major bleeding with oral anticoagulation therapy (1.30; 0.94-1.79) than patients not on this treatment at study entry (1.27, 0.85-1.89 and 0.59, 0.32-1.08, respectively).Conclusion Oral anticoagulation therapy is superior to clopidogrel plus aspirin for prevention of vascular events in patients with atrial fibrillation at high risk of stroke, especially in those already taking oral anticoagulation therapy.

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The importance of mean time in therapeutic range for complication rates in warfarin therapy of patients with atrial fibrillation: A systematic review and meta-regression analysis
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“Four papers[16,18,19,21] on the same patient cohort were retained as they held information on outcomes of interest not reported in the otherwise included papers on that patient cohort [6,15,17,22].”
Background
Laparoscopic cholecystectomy for the various types of gallbladder inflammation: a prospective trial.
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on behalf of Grupo de trabajo de Riesgo vascular de la, S. E. M. I., Fernández, C. S., Formiga, F., Camafort, M., Rodrigo, J. M. C., Díez‐Manglano, J., Reino, A. P., Tiberio, G., & Mostaza, J. M. (2015) · BMC Cardiovascular Disorders · doi:10.1186/s12872-015-0137-7 · Cited by 75
“In the ACTIVE-W trial, warfarin was superior to clopidogrel plus aspirin for the prevention of vascular events in patients with AF at high risk of stroke, especially in those subjects already taking oral anticoagulation therapy [14].”
Background
Effect of pharmacological therapies for stroke prevention on major gastrointestinal bleeding in patients with atrial fibrillation
Coleman, C. I., Sobieraj, D. M., Winkler, S., Cutting, P., Mediouni, M., Alikhanov, S., & Kluger, J. (2011) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2011.02809.x · Cited by 73
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Method
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Corresponding author: ‡
Venue: The Lancet
Publisher: Elsevier BV
Published: 2006-06
Volume: 367
Issue: 9526
Pages: 1903-1912
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(06)68845-4
OpenAlex: W2159193915
Cited by: 1,952
References: 24
Citations by year: 2026: 20 · 2025: 22 · 2024: 33 · 2023: 44 · 2022: 44 · 2021: 68 · 2020: 68 · 2019: 82 · 2018: 92 · 2017: 87 · 2016: 107 · 2015: 118 · 2014: 134 · 2013: 155 · 2012: 208
FWCI: 77.72
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
Funders: Bristol-Myers Squibb
Sanofi
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: atrial fibrillation, clopidogrel, aspirin, oral anticoagulation, stroke prevention, vascular events, major bleeding, anticoagulation monitoring, clopidogrel resistance, irbesartan, antiplatelet therapy, vascular death, myocardial infarction
MeSH terms: Clopidogrel, Irbesartan, Aged, Anticoagulants, Aspirin, Atrial Fibrillation, Biphenyl Compounds, Drug Therapy, Combination, Humans, Platelet Aggregation Inhibitors, Risk Factors, Severity of Illness Index, Tetrazoles, Ticlopidine, International Normalized Ratio, Stroke

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Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial

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