Skip to Main content Skip to Navigation
Journal articles

CLOSE: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design

Jean-Louis Mas Geneviève Derumeaux 1 Pierre Amarenco 2, 3 Caroline Arquizan Pierre Aubry 3 Martine Barthelet Bernard Bertrand Eric Brochet 3 Laure Cabanes Erwan Donal 4, 5, 6 Jean-Luc Dubois-Randé 7, 1 Isabelle Durand-Zaleski Laura Ernande Gérard Finet 8 Alain Fraisse 9 Maurice Giroud 10 Patrice Guerin 11 Gilbert Habib 12, 13 Jean-Michel Juliard 3 Didier Leys 14 Michel Lievre 15 Jean-René Lusson 16, 17 François Marçon 18 Patrick Michel Thierry Moulin Francois Mounier-Vehier Luc Pierard 19 Christophe Piot 20 Christian Rey Gilles Rodier Raymond Roudaut Jean-Marc Schleich 5, 21 Emmanuel Teiger 22, 1, 7 Guillaume Turc 23 Fabrice Vuillier Christian Weimar 24 France Woimant 25, 26 Gilles Chatellier 27, 28
15 Evaluation et modélisation des effets thérapeutiques
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
Abstract : Rationale 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 Aim 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. Sample size Six hundred and sixty-four patients were included in the study. Methods and design 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. Study outcomes 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. Discussion 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.
Document type :
Journal articles
Complete list of metadatas

https://hal-univ-rennes1.archives-ouvertes.fr/hal-01414463
Contributor : Laurent Jonchère <>
Submitted on : Monday, December 12, 2016 - 12:44:16 PM
Last modification on : Friday, October 16, 2020 - 5:22:16 PM

Identifiers

Citation

Jean-Louis Mas, Geneviève Derumeaux, Pierre Amarenco, Caroline Arquizan, Pierre Aubry, et al.. CLOSE: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. International Journal of Stroke, Wiley, 2016, 11 (6), pp.724--732. ⟨10.1177/1747493016643551⟩. ⟨hal-01414463⟩

Share

Metrics

Record views

870