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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
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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“VKA therapy prevents stroke, non-central nervous system embolus, myocardial infarction, and vascular death better than single or dual antiplatelet therapy with aspirin and clopidogrel (annual risk of 5.6% for aspirin and clopidogrel vs. 3.9% with VKA therapy).431”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [431]
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“be inferior to oral anticoagulation in stroke prevention in AF patients.(3,11) Newer generation antiplatelet agents such as ticagrelor,”
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VanDerWerf, J. D., & Kumar, M. A. (2017) · Handbook of clinical neurology · doi:10.1016/b978-0-444-63599-0.00040-5 · Cited by 14
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Acute myocardial infarction, intraventricular thrombus and risk of systemic embolism
Hudec, Š., Hutyra, M., Přeček, J., Latal, J., Nykl, R., Špaček, M., Sluka, M., Šaňák, D., Tüdös, Z., Navrátil, K., et al. (2020) · Biomedical Papers · doi:10.5507/bp.2020.001 · Cited by 14
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Metadata
- Authors
- ‡
- 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
- 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
- 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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