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Title: Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques.
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: 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; 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.).
Issue Date: 3-Apr-2014
Citation: 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.
Internal ID Number: 24699050
DOI: 10.1161/STROKEAHA.113.004251
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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