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Title: Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques.
Austin Authors: Amarenco, Pierre;Davis, Stephen M;Jones, Elizabeth F ;Cohen, Ariel A;Heiss, Wolf-Dieter;Kaste, Markku;Laouénan, Cédric;Young, Dennis;Macleod, Malcolm R;Donnan, Geoffrey A 
Institutional Author: Aortic Arch Related Cerebral Hazard Trial Investigators
Affiliation: Department of Neurology, Royal Melbourne Hospital (S.D.) and Florey Institute of Neuroscience and Mental Health (D.Y., M.M., G.A.D.), University of Melbourne, Melbourne, Australia
Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia (E.F.J.); Max Planck Institute for Neurological Research, Cologne, Germany (W.-D.H.); Department of Neurology, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland (M.K.); Stroke and Ageing Research Centre, Monash University, Melbourne, Australia (D.Y.); and Division of Clinical Neurosciences, University of Edinburgh (SC005336), Scotland, United Kingdom (M.M.).
From the Department of Neurology, Stroke Centre, DHU FIRE, INSERM U 1148, Paris Diderot-Sorbonne University, Hôpital Bichat (P.A.), Department of Cardiology, Saint-Antoine Hospital and Medical School, Univeristé Pierre et Marie Curie (A.A.C.), and Department of Biostatistics, Paris-Diderot-Sorbonne University, Hôpital Bichat (C.L.), Assistance Publique-Hôpitaux de Paris, Paris, France
Issue Date: 3-Apr-2014
Publication information: Stroke; A Journal of Cerebral Circulation 2014; 45(5): 1248-57
Abstract: Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear.This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta>4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization.The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups.Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating. Unique identifier: NCT00235248.
Gov't Doc #: 24699050
DOI: 10.1161/STROKEAHA.113.004251
Journal: Stroke
Type: Journal Article
Subjects: aorta
cerebral infarction
Aged, 80 and over
Anticoagulants.administration & dosage.pharmacology
Aorta, Thoracic.pathology
Aortic Diseases.drug therapy.epidemiology.mortality
Aspirin.administration & dosage.pharmacology
Brain Ischemia.drug therapy.epidemiology.mortality
Drug Therapy, Combination
Embolism.drug therapy.epidemiology.mortality
Middle Aged
Plaque, Atherosclerotic.drug therapy.epidemiology.mortality
Platelet Aggregation Inhibitors.administration & dosage.pharmacology
Prospective Studies
Single-Blind Method
Stroke.drug therapy.epidemiology.mortality
Ticlopidine.administration & dosage.analogs & derivatives.pharmacology
Treatment Outcome
Warfarin.administration & dosage.pharmacology
Appears in Collections:Journal articles

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