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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Task Force Members, Lip, G. Y. H., Windecker, S., Huber, K., Kirchhof, P. F., Marín, F. R., ten Berg, J. M., Hæusler, K. G., Boriani, G., Capodanno, D., et al. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu298 · Cited by 573
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Result
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation
Andrade, J. G., Aguilar, M., Atzema, C. L., Bell, A., Cairns, J. A., Cheung, C. C., Cox, J. L., Dorian, P., Gladstone, D. J., Healey, J. S., et al. (2020) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2020.09.001 · Cited by 593
The Clinical Impact of Incomplete Left Atrial Appendage Closure With the Watchman Device in Patients With Atrial Fibrillation
Viles-González, J. F., Kar, S., Douglas, P. S., Dukkipati, S. R., Feldman, T. E., Horton, R., Holmes, D. R., & Reddy, V. Y. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.11.028 · Cited by 545
Independent predictors of stroke in patients with atrial fibrillation
The Stroke Risk in Atrial Fibrillation Working Group (2007) · Neurology · doi:10.1212/01.wnl.0000267275.68538.8d · Cited by 545
New Antithrombotic Drugs
Weitz, J. I., Eikelboom, J. W., & Samama, M. M. (2012) · CHEST Journal · doi:10.1378/chest.11-2294 · Cited by 539
Anticoagulation Control and Prediction of Adverse Events in Patients With Atrial Fibrillation: A Systematic Review
Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., Glasziou, P., Bankhead, C., & Xu, Y. (2008) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.108.796185 · Cited by 514
Rivaroxaban—Once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: Rationale and Design of the ROCKET AF study
The Executive Steering Committee, O. B. O. T. R. A. S. I. (2010) · American Heart Journal · doi:10.1016/j.ahj.2009.11.025 · Cited by 478
2021 Focused Update Consensus Guidelines of the Asia Pacific Heart Rhythm Society on Stroke Prevention in Atrial Fibrillation: Executive Summary
Chao, T., Joung, B., Takahashi, Y., Lim, T. W., Choi, E., Chan, Y., Guo, Y., Sriratanasathavorn, C., Oh, S., Okumura, K., et al. (2021) · Thrombosis and Haemostasis · doi:10.1055/s-0041-1739411 · Cited by 476
Incidence of Stroke in Paroxysmal Versus Sustained Atrial Fibrillation in Patients Taking Oral Anticoagulation or Combined Antiplatelet Therapy
Hohnloser, S. H., Pajitnev, D., Pogue, J. M., Healey, J. S., Pfeffer, M. A., Yusuf, S., & Connolly, S. J. (2007) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2007.07.076 · Cited by 459
Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation (ARISTOTLE) trial: Design and rationale
Lópes, R. D., Alexander, J. H., Al‐Khatib, S. M., Ansell, J., Diaz, R., Easton, J. D., Gersh, B. J., Granger, C. B., Hanna, M., Horowitz, J. D., et al. (2010) · American Heart Journal · doi:10.1016/j.ahj.2009.07.035 · Cited by 457
Antithrombotic and Thrombolytic Therapy for Ischemic Stroke
Lansberg, M. G., O'Donnell, M. J., Khatri, P., Lang, E., Nguyen‐Huynh, M. N., Schwartz, N. E., Sonnenberg, F. A., Schulman, S., Vandvik, P. O., Spencer, F. A., et al. (2012) · CHEST Journal · doi:10.1378/chest.11-2302 · Cited by 459
Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation
Fiedler, K. A., Mæng, M., Mehilli, J., Schüpke, S., Byrne, R. A., Sibbing, D., Hoppmann, P., Schneider, S., Fusaro, M., Ott, I., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.02.050 · Cited by 455
“However, randomized trials have shown that DAPT is inferior to OAC for reducing the risk of thromboembolic events in patients with atrial fibrillation (3) or with mechanical heart valves (4).”
Background
Incidence, outcome, risk factors, and long-term prognosis of cryptogenic transient ischaemic attack and ischaemic stroke: a population-based study
Li, L.-X., Yiin, G., Geraghty, O., Schulz, U., Küker, W., Mehta, Z., & Rothwell, P. (2015) · Lancet Neurology · doi:10.1016/s1474-4422(15)00132-5 · Cited by 397
Warfarin use associates with increased risk for stroke in hemodialysis patients with atrial fibrillation
Chan, K. E., Lazarus, J. M., Thadhani, R., & Hakim, R. M. (2009) · Journal of the American Society of Nephrology · doi:10.1681/asn.2009030319 · Cited by 431
Reducing the Global Burden of Cardiovascular Disease, Part 2
Leong, D. P., Joseph, P. G., McKee, M., Anand, S. S., Teo, K. K., Schwalm, J.-D., & Yusuf, S. (2017) · Circulation Research · doi:10.1161/circresaha.117.311849 · Cited by 428
Intracranial Hemorrhage in Atrial Fibrillation Patients During Anticoagulation With Warfarin or Dabigatran
Hart, R. G., Diener, H., Yang, S., Connolly, S. J., Wallentin, L. C., Reilly, P. A., Ezekowitz, M. D., & Yusuf, S. (2012) · Stroke · doi:10.1161/strokeaha.112.650614 · Cited by 408
Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated
Gladstone, D. J., Bui, E., Fang, J., Laupacis, A., Lindsay, M. P., Tu, J. V., Silver, F. L., & Kapral, M. K. (2008) · Stroke · doi:10.1161/strokeaha.108.516344 · Cited by 402
2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran)
Wann, L. S., Curtis, A. B., Ellenbogen, K. A., Estes, N. A. M., Ezekowitz, M. D., Jackman, W. M., January, C. T., Lowe, J. E., Page, R. L., Slotwiner, D. J., et al. (2011) · Heart Rhythm · doi:10.1016/j.hrthm.2011.01.032 · Cited by 394
Outcome parameters for trials in atrial fibrillation: executive summary: Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA)
Kirchhof, P. F., Auricchio, A., Bax, J. J., Crijns, H. J. G. M., Camm, A. J., Diener, H., Goette, A., Hindricks, G., Hohnloser, S., KAPPENBERGER, L. J., et al. (2007) · European Heart Journal · doi:10.1093/eurheartj/ehm358 · Cited by 382
Antiplatelet Drugs
Eikelboom, J. W., Hirsh, J., Spencer, F. A., Baglin, T. P., & Weitz, J. I. (2012) · CHEST Journal · doi:10.1378/chest.11-2293 · Cited by 389
Parenteral anticoagulants in heart disease: Current status and perspectives (Section II)
Husted, S., Wallentin, L. C., Andreotti, F., Arnesen, H., Bachmann, F., Baigent, C., Huber, K., Jespersen, J., Kristensen, S. D., Lip, G. Y. H., et al. (2013) · Thrombosis and Haemostasis · doi:10.1160/th12-06-0403 · Cited by 366
EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
Glikson, M., Wolff, R., Hindricks, G., Mandrola, J. M., Camm, A. J., Lip, G. Y. H., Fauchier, L., Betts, T. R., Lewalter, T., Saw, J., et al. (2020) · EuroIntervention · doi:10.4244/eijy19m08_01 · Cited by 374
Primary and Secondary Prevention of Ischemic Stroke and Cerebral Hemorrhage
Diener, H., & Hankey, G. J. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.12.072 · Cited by 394
CYP2C9 Genotype-guided Warfarin Prescribing Enhances the Efficacy and Safety of Anticoagulation: A Prospective Randomized Controlled Study
Caraco, Y., Blotnick, S., & Muszkat, M. (2007) · Clinical Pharmacology & Therapeutics · doi:10.1038/sj.clpt.6100316 · Cited by 359
Clinical Aspects of Platelet Inhibitors and Thrombus Formation
Meadows, T. A., & Bhatt, D. L. (2007) · Circulation Research · doi:10.1161/01.res.0000264509.36234.51 · Cited by 353
Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial
Hohnloser, S. H., Oldgren, J., Yang, S., Wallentin, L. C., Ezekowitz, M. D., Reilly, P. A., Eikelboom, J. W., Brueckmann, M., Yusuf, S., & Connolly, S. J. (2012) · Circulation · doi:10.1161/circulationaha.111.055970 · Cited by 351
Atrial fibrillation
Lip, G. Y. H., Tse, H., & Lane, D. A. (2011) · The Lancet · doi:10.1016/s0140-6736(11)61514-6 · Cited by 347
Oral Anticoagulation and Antiplatelets in Atrial Fibrillation Patients After Myocardial Infarction and Coronary Intervention
Lamberts, M., Gislason, G., Olesen, J. B., Kristensen, S. L., Olsen, A. S., Mikkelsen, A. P., Christensen, C. B., Lip, G. Y. H., Køber, L., Torp-Pedersen, C. T., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.05.029 · Cited by 339
“factors and dual antiplatelet therapy being indicated after ACS or PCI(1,18-20) _ENREF_1.”
Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation
Shah, S. V., & Gage, B. F. (2011) · Circulation · doi:10.1161/circulationaha.110.985655 · Cited by 334
Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran
Ezekowitz, M. D., Connolly, S. J., Parekh, A., Reilly, P. A., Varrone, J., Wang, S., Oldgren, J., Themeles, E., Wallentin, L. C., & Yusuf, S. (2009) · American Heart Journal · doi:10.1016/j.ahj.2009.02.005 · Cited by 332
EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
Glikson, M., Wolff, R., Hindricks, G., Mandrola, J. M., Camm, A. J., Lip, G. Y. H., Fauchier, L., Betts, T. R., Lewalter, T., Saw, J., et al. (2019) · EP Europace · doi:10.1093/europace/euz258 · Cited by 341
Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve
Rodés‐Cabau, J., Masson, J., Welsh, R. C., del Blanco, B. G., Pelletier, M. P., Webb, J. G., Alqoofi, F., Généreux, P., Maluenda, G., Thoenes, M., et al. (2017) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2017.04.014 · Cited by 331
“Indeed, DAPT has been associated with a risk for bleeding events similar to that of anticoagulation therapy (31).”
Background
Antithrombotic and Thrombolytic Therapy for Ischemic Stroke
Albers, G. W., Amarenco, P., Easton, J. D., Sacco, R. L., & Teal, P. A. (2008) · CHEST Journal · doi:10.1378/chest.08-0720 · Cited by 318
Effect of Age on Stroke Prevention Therapy in Patients With Atrial Fibrillation
van Walraven, C., Hart, R. G., Connolly, S. J., Austin, P. C., Mant, J., Hobbs, R. F., Koudstaal, P. J., Petersen, P., Pérez-Gómez, F., Knottnerus, J. A., et al. (2009) · Stroke · doi:10.1161/strokeaha.108.526988 · Cited by 312
Comparison of Risk Stratification Schemes to Predict Thromboembolism in People With Nonvalvular Atrial Fibrillation
Fang, M. C., Go, A. S., Chang, Y., Borowsky, L. H., Pomernacki, N. K., & Singer, D. E. (2008) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2007.09.065 · Cited by 311
2020 ACC Expert Consensus Decision Pathway for Anticoagulant and Antiplatelet Therapy in Patients With Atrial Fibrillation or Venous Thromboembolism Undergoing Percutaneous Coronary Intervention or With Atherosclerotic Cardiovascular Disease
Kumbhani, D. J., Cannon, C. P., Beavers, C. J., Bhatt, D. L., Cuker, A. C., Gluckman, T. J., Marine, J. E., Mehran, R., Messe, S. R., Patel, N. S., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.09.011 · Cited by 320
“In addition, approximately 10% of patients with recent percutaneous coronary intervention (PCI) have concomitant AF (17,18).”
BackgroundResult
Management of Antithrombotic Therapy in Atrial Fibrillation Patients Presenting with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention/ Stenting
Huber, K., Andreotti, F., Arnesen, H., Airaksinen, J. K. E., Cuisset, T., Kirchhof, P. F., Marín, F. R., & Lip, G. Y. H. (2009) · Thrombosis and Haemostasis · doi:10.1160/th09-08-0580 · Cited by 304
Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
Angiolillo, D. J., Bhatt, D. L., Cannon, C. P., Eikelboom, J. W., Gibson, C. M., Goodman, S. G., Granger, C. B., Holmes, D. R., Lópes, R. D., Mehran, R., et al. (2021) · Circulation · doi:10.1161/circulationaha.120.050438 · Cited by 305
Oral Anticoagulant Therapy Prescription in Patients With Atrial Fibrillation Across the Spectrum of Stroke Risk
Hsu, J. C., Maddox, T. M., Kennedy, K. F., Katz, D. F., Marzec, L., Lubitz, S. A., Gehi, A. K., Turakhia, M. P., & Marcus, G. M. (2016) · JAMA Cardiology · doi:10.1001/jamacardio.2015.0374 · Cited by 302
Outcome parameters for trials in atrial fibrillation: Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork and the European Heart Rhythm Association
Kirchhof, P., Auricchio, A., Bax, J., Crijns, H., Camm, J., Diener, H.-C., Goette, A., Hindricks, G., Hohnloser, S., Kappenberger, L., et al. (2007) · Europace · doi:10.1093/europace/eum191 · Cited by 293
Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter
Cairns, J. A., Connolly, S. J., McMurtry, S., Stephenson, M., & Talajic, M. R. (2011) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2010.11.007 · Cited by 285
Platelets and Their Role in Hemostasis and Thrombosis—From Physiology to Pathophysiology and Therapeutic Implications
Scridon, A. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232112772 · Cited by 332
“Similar results were also reported for patients with atrial fibrillation [47,48].”
Result
Safety and efficacy of combined antiplatelet-warfarin therapy after coronary stenting
Karjalainen, P. P., Porela, P., Ylitalo, A., Vikman, S., Nyman, K., Vaittinen, M.-A., Airaksinen, T. J., Niemelä, M., Vahlberg, T. J., & Airaksinen, J. K. E. (2007) · European Heart Journal · doi:10.1093/eurheartj/ehl488 · Cited by 286
Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation Patients Taking an Oral Anticoagulant
Lamberts, M., Gislason, G., Lip, G. Y. H., Lassen, J. F., Olesen, J. B., Mikkelsen, A. P., Sørensen, R., Køber, L., Torp-Pedersen, C. T., & Hansen, M. L. (2014) · Circulation · doi:10.1161/circulationaha.113.004834 · Cited by 286
“Proton pump inhibitors 840 (26) 158 (38) 484 (27) 194 (20) 310 (21) 73 (23) 112 (22)”
Bleeding risk assessment and management in atrial fibrillation patients
Fauchier, L., Hylek, E. M., Knight, E., Lane, D. A., Levi, M. M., Marín, F. R., Palareti, G., Jp, C., Rubboli, A., Poli, D., et al. (2011) · Thrombosis and Haemostasis · doi:10.1160/th11-10-0690 · Cited by 283
Ibrutinib‐associated bleeding: pathogenesis, management and risk reduction strategies
Shatzel, J. J., Olson, S. R., Tao, D. L., McCarty, O. J. T., Danilov, A. V., & DeLoughery, T. G. (2017) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13651 · Cited by 281
Moving the Tipping Point
Eckman, M. H., Singer, D. E., Rosand, J. M., & Greenberg, S. M. (2010) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.110.958108 · Cited by 280

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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