Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques

BACKGROUND AND PURPOSE—Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. METHODS—This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) teste...

Full description

Saved in:

Bibliographic Details
Published in:	Stroke (1970) Vol. 45; no. 5; pp. 1248 - 1257
Main Authors:	Amarenco, Pierre, Davis, Stephen, Jones, Elizabeth F, Cohen, Ariel A, Heiss, Wolf-Dieter, Kaste, Markku, Laouénan, Cédric, Young, Dennis, Macleod, Malcolm, Donnan, Geoffrey A, Bladin, Christopher F, Chambers, Brian R, Frayne, Judith, Hankey, Graeme J, Levi, Christopher R, Read, Stephen J, Ravaud, Philippe, Tatlisumak, Turgut, Soinne, Lauri, Laine, Mika, Syvänne, Mikko, Vikatmaa, Pirkka, Lepäntalo, Mauri, Mentré, France, Gosset, Simon, Churilov, Leonid, De Broucker, Thomas, Favrole, Pascal, Mawet, Jérôme, Mocquard, Yves, Obadia, Michael, Godefroy, Olivier, Hosseini, Hassan, Pico, Fernando, Garnier, Pierre, Malbec, Marcel, Pinel, Jean-François, Ille, Olivier, Vadamme, Xavier, Macian-Montoro, Francisco, Servan, Jérôme, Viallet, François, Rosolacci, Thierry, Lecoz, Patrick, Clavelou, Pierre, Detante, Olivier, Cho, Tae-Hee, Saudeau, Denis, Michel, Patrik, D’Ombrogio, Suzette, Serisier, David, Sturm, Jonathon, Kimber, Thomas, Marcus, Romesh, Schwartz, Ray, Helme, Rob, Blacker, David, Wood, Jonathan
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD American Heart Association, Inc 01-05-2014 Lippincott Williams & Wilkins American Heart Association
Subjects:	Aged Aged, 80 and over Anticoagulants - administration & dosage Anticoagulants - pharmacology Aorta, Thoracic - pathology Aortic Diseases - drug therapy Aortic Diseases - epidemiology Aortic Diseases - mortality Aspirin - administration & dosage Aspirin - pharmacology Atherosclerosis (general aspects, experimental research) Biological and medical sciences Blood and lymphatic vessels Brain Ischemia - drug therapy Brain Ischemia - epidemiology Brain Ischemia - mortality Cardiology. Vascular system Drug Therapy, Combination Embolism - drug therapy Embolism - epidemiology Embolism - mortality Female Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Human health and pathology Humans Life Sciences Male Medical sciences Middle Aged Nervous system (semeiology, syndromes) Neurology Plaque, Atherosclerotic - drug therapy Plaque, Atherosclerotic - epidemiology Plaque, Atherosclerotic - mortality Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - pharmacology Prospective Studies Single-Blind Method Stroke - drug therapy Stroke - epidemiology Stroke - mortality Ticlopidine - administration & dosage Ticlopidine - analogs & derivatives Ticlopidine - pharmacology Treatment Outcome Vascular diseases and vascular malformations of the nervous system Warfarin - administration & dosage Warfarin - pharmacology Prostaglandin-endoperoxide synthase Coumarine derivatives Cardiovascular disease Anticoagulant Acetylsalicylic acid Vascular disease Antivitamin K Atherosclerosis Antithrombotic agent Aorta Salicylates Cerebrovascular disease Human Cerebral infarction Stroke Nervous system diseases Warfarin Enzyme Enzyme inhibitor Antiplatelet agent Cerebral disorder Non steroidal antiinflammatory agent Analgesic Aortic arch Central nervous system disease Antipyretic Clopidogrel Oxidoreductases Thienopyridine derivative Comparative study atherosclerosis cerebral infarction aorta
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	BACKGROUND AND PURPOSE—Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. METHODS—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. RESULTS—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. CONCLUSIONS—Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00235248.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0039-2499 1524-4628
DOI:	10.1161/STROKEAHA.113.004251