title: close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design.
abstract: Currently available data do not provide definitive evidence on the comparative benefits of closure of patent foramen ovale, oral anticoagulants and antiplatelet therapy in patients with patent foramen ovale-associated cryptogenic stroke
  
  
  
  To assess whether transcatheter patent foramen ovale closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy, for secondary stroke prevention in patients aged 16 to 60 years with a large patent foramen ovale or a patent foramen ovale associated with an atrial septal aneurysm, and an otherwise unexplained ischaemic stroke or retinal ischaemia.
  
  
  
  Six hundred and sixty-four patients were included in the study.
  
  
  
  CLOSE is an academic-driven, multicentre, randomized, open-label, three-group, superiority trial with blinded adjudication of outcome events. The trial has been registered with Clinical Trials Register (Clinicaltrials.gov, NCT00562289). Patient recruitment started in December 2007. Patient follow-up will continue until December 2016. Expected mean follow-up = 5.6 years.
  
  
  
  The primary efficacy outcome is the occurrence of fatal or nonfatal stroke. Safety outcomes include fatal, life-threatening or major procedure- or device-related complications and fatal, life-threatening or major haemorrhagic complications.
  
  
  
  CLOSE is the first specifically designed trial to assess the superiority of patent foramen ovale closure over antiplatelet therapy alone and the superiority of oral anticoagulants over antiplatelet therapy to prevent stroke recurrence in patients with patent foramen ovale-associated cryptogenic stroke.
authors.affiliation: Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, Inserm 894, DHU NeuroVasc, Paris, France jl.mas@ch-sainte-anne.fr.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Mas
authors.affiliation: Department of Physiology, Henri Mondor Hospital, Paris Est Créteil University, Inserm 955, DHU ATVB, Créteil, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Derumeaux
authors.affiliation: APHP, Department of Neurology and Stroke Center, Bichat Hospital, Paris-Diderot University, Inserm 1148, DHU FIRE, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Amarenco
authors.affiliation: Department of Neurology, Gui de Chauliac Hospital, Montpellier, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Arquizan
authors.affiliation: APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Aubry
authors.affiliation: Department of Cardiovascular Investigations, Louis Pradel Hospital, Lyon University, Bron, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Barthelet
authors.affiliation: Department of Cardiology, CHU A. Michallon, Joseph Fourier University, Grenoble, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Bertrand
authors.affiliation: APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Brochet
authors.affiliation: AP-HP, Department of Cardiology, Cochin Hospital, Paris-Descartes University, Paris, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Cabanes
authors.affiliation: Department of Cardiology and Vascular Diseases, Pontchaillou Hospital, Rennes University, Rennes, France.
authors.forename: Erwan
authors.initials: E
authors.lastname: Donal
authors.affiliation: APHP, Department of Cardiology, Henri-Mondor Hospital, Paris Est Créteil University, Inserm 955, DHU ATVB, Créteil, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Dubois-Randé
authors.affiliation: AP-HP, Department of Public Health, Henri Mondor Hospital, Paris Est Créteil University, Créteil, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.affiliation: Department of Physiology, Henri Mondor Hospital, Paris Est Créteil University, Inserm 955, DHU ATVB, Créteil, France.
authors.forename: Laura
authors.initials: L
authors.lastname: Ernande
authors.affiliation: Department of Cardiology, Cardiovascular Hospital, Claude Bernard University, Inserm 1060, Lyon, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Finet
authors.affiliation: Department of Pediatric Cardiology, La Timone Hospital, Aix-Marseille Université, Marseille, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Fraisse
authors.affiliation: Department of Neurology, CHU Dijon, Bourgogne University, Dijon Stroke Registry, Dijon France.
authors.forename: Maurice
authors.initials: M
authors.lastname: Giroud
authors.affiliation: Department of Cardiology, Institut du Thorax, CHU Nantes, Nantes, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Guérin
authors.affiliation: Department of Cardiology, La Timone Hospital, Aix-Marseille Université, Marseille France.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Habib
authors.affiliation: APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Juliard
authors.affiliation: Department of Neurology and Stroke Unit, Roger Salengro Hospital, Lille 2 University, Inserm 1171, Lille, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Leys
authors.affiliation: UMR CNRS 5558, Lyon 1 University, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Lièvre
authors.affiliation: Department of Cardiology and Vascular Diseases, Gabriel Montpied Hospital, Auvergne University, UMR 6284 Clermont-Ferrand, France.
authors.forename: Jean-René
authors.initials: JR
authors.lastname: Lusson
authors.affiliation: Department of Cardiovascular Diseases, Pediatric Cardiology Unit, Nancy University, Nancy, France.
authors.forename: François
authors.initials: F
authors.lastname: Marcon
authors.affiliation: Stroke Center, Department of Neurology, Centre Hospitalier Universitaire Vaudois and Lausanne University, Lausanne, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Michel
authors.affiliation: Department of Neurology, CHU Besancon, Franche-Comté University, CIC 1431, Besancon, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Moulin
authors.affiliation: Department of Neurology, Doctor Schaffner Hospital, Lens, France.
authors.forename: François
authors.initials: F
authors.lastname: Mounier-Vehier
authors.affiliation: Department of Cardiology, Sart Tilman Hospital, Liège University, Liège, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Pierard
authors.affiliation: Department of Interventional Cardiology, Clinique du Millénaire, Montpellier University, UMR 5203, Montpellier, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Piot
authors.affiliation: Department of Pediatric Cardiology, Cardiology Hospital, Lille 2 University, Lille, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Rey
authors.affiliation: Department of Neurology, Annecy-Genevois Hospital, Annecy, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rodier
authors.affiliation: Department of Cardiology and Vascular Diseases, Haut Leveque Hospital, Bordeaux University, Bordeaux, France.
authors.forename: Raymond
authors.initials: R
authors.lastname: Roudaut
authors.affiliation: Department of Cardiology and Vascular Diseases, Pontchaillou Hospital, Rennes University, Rennes, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Schleich
authors.affiliation: Department of Physiology, Henri Mondor Hospital, Paris Est Créteil University, Inserm 955, DHU ATVB, Créteil, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.affiliation: Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, Inserm 894, DHU NeuroVasc, Paris, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Turc
authors.affiliation: Department of Neurology, CHU Besancon, Franche-Comté University, CIC 1431, Besancon, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Vuillier
authors.affiliation: Department of Neurology, University Hospital, University of Duisburg-Essen, Essen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Weimar
authors.affiliation: APHP, Department of Neurology, Lariboisière Hospital, Agence Régionale de Santé Île-de-France, Paris, France.
authors.forename: France
authors.initials: F
authors.lastname: Woimant
authors.affiliation: APHP, Epidemiology and Clinical Research Unit, Georges Pompidou European hospital, Paris Descartes University, Paris, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000191:economics; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000191:economics; D055502:Secondary Prevention / Q000191:economics; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors
keywords: Ischaemic stroke; antiplatelet therapy; oral anticoagulants; patent foramen ovale; transcatheter PFO closure