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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Ewen, S., Rettig‐Ewen, V., Mahfoud, F., Böhm, M., & Laufs, U. (2013) · Clinical Research in Cardiology · doi:10.1007/s00392-013-0616-8 · Cited by 49
Is the left atrial appendage more than a simple appendage?
Hara, H., Virmani, R., Holmes, D. R., Buchbinder, M., Lesser, J. R., Tassel, R. A. V., Mooney, M. R., & Schwartz, R. S. (2009) · Catheterization and Cardiovascular Interventions · doi:10.1002/ccd.21983 · Cited by 50
A clinical decision aid for the selection of antithrombotic therapy for the prevention of stroke due to atrial fibrillation
LaHaye, S. A., Gibbens, S. L., Ball, D. G. A., Day, A. G., Olesen, J. B., & Skanes, A. C. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs167 · Cited by 50
Don’t add aspirin for associated stable vascular disease in a patient with atrial fibrillation receiving anticoagulation
Lip, G. Y. H. (2008) · BMJ · doi:10.1136/bmj.39351.706586.ad · Cited by 49
Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction
Bonaca, M. P., Goto, S., Bhatt, D. L., Steg, P. G., Storey, R. F., Cohen, M. C., Goodrich, E. L., Mauri, L., Ophuis, T. O., Ruda, M., et al. (2016) · Circulation · doi:10.1161/circulationaha.116.024637 · Cited by 52
Anticoagulation in patients with atrial fibrillation undergoing coronary stent implantation
Bernard, A., Fauchier, L., Pellegrin, C., Clementy, N., Etienne, C. S., Banerjee, A., Naudin, D., & Angoulvant, D. (2013) · Thrombosis and Haemostasis · doi:10.1160/th13-04-0351 · Cited by 55
Safety and effectiveness of antithrombotic strategies in older adult patients with atrial fibrillation and non–ST elevation myocardial infarction
Fosbøl, E. L., Wang, T. Y., Li, S., Piccini, J. P., Lópes, R. D., Shah, B. R., Mills, R. M., Klaskala, W. I., Alexander, K. P., Thomas, L. E., et al. (2012) · American Heart Journal · doi:10.1016/j.ahj.2012.01.017 · Cited by 48
Rivaroxaban, an oral direct factor Xa inhibitor
Piccini, J. P., Patel, M. R., Mahaffey, K. W., Fox, K. A. A., & Califf, R. M. (2008) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.17.6.925 · Cited by 48
Left Atrial Appendage Occlusion Eliminates the Need for Warfarin
Holmes, D. R., & Schwartz, R. S. (2009) · Circulation · doi:10.1161/circulationaha.108.844761 · Cited by 48
Prophylactic Warfarin Therapy After Primary Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction
May, M. R. L., Acharya, S., Wells, G. A., Burwash, I. G., Chong, A., So, D. Y. F., Glover, C. A., Froeschl, M. P. V., Hibbert, B. M., Marquis, J.-F., et al. (2014) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2014.07.018 · Cited by 47
Effect of Race/Ethnicity on the Efficacy of Warfarin
Shen, A. Y., Chen, W., Yao, J. F., Brar, S. S., Wang, X., & Go, A. S. (2008) · CNS Drugs · doi:10.2165/00023210-200822100-00003 · Cited by 47
Soluble CD40 Ligand, Platelet Surface CD40 Ligand, and Total Platelet CD40 Ligand in Atrial Fibrillation
Choudhury, A., Chung, I. K.-K., Panja, N., Patel, J. V., & Lip, G. Y. H. (2008) · CHEST Journal · doi:10.1378/chest.07-2745 · Cited by 47
The Business Case for Quality Improvement
Rose, A. J., Berlowitz, D. R., Ash, A. S., Ozonoff, A., Hylek, E. M., & Goldhaber‐Fiebert, J. D. (2011) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.111.960591 · Cited by 47
Warfarin and atrial fibrillation: from ideal to real the warfarin affaire
Molteni, M., & Cimminiello, C. (2014) · Thrombosis Journal · doi:10.1186/1477-9560-12-5 · Cited by 48
Contemporary Management of Atrial Fibrillation: What Can Clinical Registries Tell Us About Stroke Prevention and Current Therapeutic Approaches?
Lip, G. Y. H., Al‐Khatib, S. M., Cosío, F. G., Banerjee, A., Savelieva, I., Ruskin, J. N., Blendea, D. C., Nattel, S., Bono, J. D., Conroy, J., et al. (2014) · Journal of the American Heart Association · doi:10.1161/jaha.114.001179 · Cited by 48
Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation†
O’Donoghue, M. L., Ruff, C. T., Giugliano, R. P., Murphy, S. A., Grip, L. T., Mercuri, M. F., Rutman, H., Shi, M., Kania, G., Čermák, O., et al. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv014 · Cited by 46
“The current observations from the ENGAGE AF-TIMI 48 trial are consistent with those from the ACTIVE-W (Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events) trial that compared warfarin to aspirin and clopidogrel for stroke prevention and found that the benefitof VKAtherapy for reduc…”
Method
Intracranial and fatal bleeding according to indication for long‐term oral anticoagulant therapy
Linkins, L., O'Donnell, M. J., Julian, J. A., & Kearon, C. (2010) · Journal of Thrombosis and Haemostasis · doi:10.1111/j.1538-7836.2010.04016.x · Cited by 47
Effect of setting, monitoring intensity and patient experience on anticoagulation control: a systematic review and meta-analysis of the literature
Dolan, G., Smith, L. A., Collins, S., & Plumb, J. (2008) · Current Medical Research and Opinion · doi:10.1185/030079908x297349 · Cited by 46
Cost‐Effectiveness of Left Atrial Appendage Closure for Stroke Reduction in Atrial Fibrillation: Analysis of Pooled, 5‐Year, Long‐Term Data
Reddy, V. Y., Akehurst, R. L., Gavaghan, M. B., Amorosi, S. L., & Holmes, D. R. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.118.011577 · Cited by 46
Combination Antiplatelet Therapy for Secondary Stroke Prevention: Enhanced Efficacy or Double Trouble?
Usman, M., Notaro, L. A., Nagarakanti, R., Brahin, E., Dessain, S. K., Gracely, E. J., & Ezekowitz, M. D. (2009) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2009.01.003 · Cited by 45
Platelet activation and induction of tissue factor in acute and chronic atrial fibrillation: Involvement of mononuclear cell-platelet interaction
Hayashi, M., Takeshita, K., Inden, Y., Ishii, H., Cheng, X. W., Yamamoto, K., & Murohara, T. (2011) · Thrombosis Research · doi:10.1016/j.thromres.2011.07.013 · Cited by 45
Detection of Atrial Fibrillation After Stroke and the Risk of Recurrent Stroke
Kamel, H., Johnson, D. R., Hegde, M., Go, A. S., Sidney, S., Sorel, M. E., Hills, N. K., & Johnston, S. C. (2011) · Journal of Stroke and Cerebrovascular Diseases · doi:10.1016/j.jstrokecerebrovasdis.2011.03.008 · Cited by 45
“thrombin inhibitors (eg, dabigatran) substantially reduces the risk of primary and recurrent stroke.(4-8)”
Background
Prevention of Cardioembolic Stroke
Freeman, W. D., & Aguilar, M. I. (2011) · Neurotherapeutics · doi:10.1007/s13311-011-0048-y · Cited by 45
Consistency of Safety and Efficacy of New Oral Anticoagulants across Subgroups of Patients with Atrial Fibrillation
Lega, J., Bertoletti, L., Gremillet, C., Chapelle, C., Mismetti, P., Cucherat, M., Vital-Durand, D., Laporte, S., & on behalf of The Meta-Embol Group (2014) · PLoS ONE · doi:10.1371/journal.pone.0091398 · Cited by 45
“In published trials, the safety and efficacy profiles of NOAC were not worse than those of VKA, irrespective of patient age and prior exposure to VKA [15,32].”
Background
Lower versus standard intensity oral anticoagulant therapy (OAT) in elderly warfarin-experienced patients with non-valvular atrial fibrillation
Cucchini, U., Denas, G., Davidson, B., Marzot, F., Jose, S. P., Iliceto, S., & Pengo, V. (2010) · Thrombosis and Haemostasis · doi:10.1160/th09-05-0311 · Cited by 44
Impact of vascular disease in predicting stroke and death in patients with atrial fibrillation: the Danish Diet, Cancer and Health cohort study
Rasmussen, L. H., Larsen, T. B., Due, K. M., Tjønneland, A. M., Overvad, K., & Lip, G. Y. H. (2011) · Journal of Thrombosis and Haemostasis · doi:10.1111/j.1538-7836.2011.04308.x · Cited by 44
The safety and efficacy of vitamin K antagonist in patients with atrial fibrillation and liver cirrhosis
Lee, S., Uhm, J., Kim, J., Pak, H., Lee, M., & Joung, B. (2014) · International Journal of Cardiology · doi:10.1016/j.ijcard.2014.11.183 · Cited by 43
Clinical Trials Update from the European Society of Cardiology Meeting 2009: AAA, RELY, PROTECT, ACTIVE-I, European CRT survey, German pre-SCD II registry, and MADIT-CRT
Cleland, J. G. F., Coletta, A. P., Yassin, A., Buga, L., Torabi, A., & Clark, A. L. (2009) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfp162 · Cited by 44
Atrial Fibrillation in Congestive Heart Failure
Seiler, J., & Stevenson, W. G. (2009) · Cardiology in Review · doi:10.1097/crd.0b013e3181c21cff · Cited by 44
Catheter Ablation for Atrial Fibrillation in Patients With Watchman Left Atrial Appendage Occlusion Device: Results from a Multicenter Registry
Turagam, M. K., Lavu, M., Afzal, M. R., Vuddanda, V. L. K., Jazayeri, M., Parikh, V. K., Atkins, D., Bommana, S., Biase, L. D., Horton, R., et al. (2016) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.13148 · Cited by 45
Percutaneous left atrial appendage closure improves left atrial mechanical function through Frank–Starling mechanism
Coisne, A., Pilato, R., Brigadeau, F., Klug, D., Marquié, C., Souissi, Z., Richardson, M., Mouton, S., Polge, A., Lancellotti, P., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.01.042 · Cited by 44
Atrial fibrillation as a complication of ibrutinib therapy: clinical features and challenges of management
Thorp, B. C., & Badoux, X. C. A. (2017) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428194.2017.1339874 · Cited by 44
Triple antithrombotic management after stent implantation: when and how?
Schömig, A., Sarafoff, N., & Seyfarth, M. (2009) · Heart · doi:10.1136/hrt.2008.160457 · Cited by 43
Characteristics of patients with atrial fibrillation prescribed antiplatelet monotherapy compared with those on anticoagulants: insights from the GARFIELD-AF registry
Verheugt, F. W. A., Gao, H., Almahmeed, W. A., Ambrosio, G., Angchaisuksiri, P., Atar, D., Bassand, J., Camm, A. J., Cools, F. J. S., Eikelboom, J. W., et al. (2017) · European Heart Journal · doi:10.1093/eurheartj/ehx730 · Cited by 43
GARFIELD-AF: A Worldwide Prospective Registry of Patients With Atrial Fibrillation at Risk of Stroke
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Therapeutic Controversies: Aspirin, Clopidogrel, and Warfarin: Is the Combination Appropriate and Effective or Inappropriate and Too Dangerous?
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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
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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