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

Détails

ID Serval
serval:BIB_8D8D62DFF83C
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design.
Périodique
International Journal of Stroke : Official Journal of the International Stroke Society
Auteur(s)
Mas J.L., Derumeaux G., Amarenco P., Arquizan C., Aubry P., Barthelet M., Bertrand B., Brochet E., Cabanes L., Donal E., Dubois-Randé J.L., Durand-Zaleski I., Ernande L., Finet G., Fraisse A., Giroud M., Guérin P., Habib G., Juliard J.M., Leys D., Lièvre M., Lusson J.R., Marcon F., Michel P., Moulin T., Mounier-Vehier F., Pierard L., Piot C., Rey C., Rodier G., Roudaut R., Schleich J.M., Teiger E., Turc G., Vuillier F., Weimar C., Woimant F., Chatellier G.
Collaborateur(s)
CLOSE investigators
ISSN
1747-4949 (Electronic)
ISSN-L
1747-4930
Statut éditorial
Publié
Date de publication
2016
Peer-reviewed
Oui
Volume
11
Numéro
6
Pages
724-732
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
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.
Pubmed
Web of science
Création de la notice
21/10/2016 16:24
Dernière modification de la notice
03/03/2018 19:16
Données d'usage