{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T01:03:48Z","timestamp":1777943028952,"version":"3.51.4"},"reference-count":21,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2016,7,9]],"date-time":"2016-07-09T00:00:00Z","timestamp":1468022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>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<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Sample size<\/jats:title>\n                    <jats:p>Six hundred and sixty-four patients were included in the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and design<\/jats:title>\n                    <jats:p>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\u2009=\u20095.6 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study outcomes<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1747493016643551","type":"journal-article","created":{"date-parts":[[2016,4,8]],"date-time":"2016-04-08T14:54:01Z","timestamp":1460127241000},"page":"724-732","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["<scp>close<\/scp>\n                    : Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design"],"prefix":"10.1177","volume":"11","author":[{"given":"Jean-Louis","family":"Mas","sequence":"first","affiliation":[{"name":"Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, Inserm 894, DHU NeuroVasc, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Genevi\u00e8ve","family":"Derumeaux","sequence":"additional","affiliation":[{"name":"Department of Physiology, Henri Mondor Hospital, Paris Est Cr\u00e9teil University, Inserm 955, DHU ATVB, Cr\u00e9teil, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Amarenco","sequence":"additional","affiliation":[{"name":"APHP, Department of Neurology and Stroke Center, Bichat Hospital, Paris-Diderot University, Inserm 1148, DHU FIRE, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Arquizan","sequence":"additional","affiliation":[{"name":"Department of Neurology, Gui de Chauliac Hospital, Montpellier, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Aubry","sequence":"additional","affiliation":[{"name":"APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martine","family":"Barthelet","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Investigations, Louis Pradel Hospital, Lyon University, Bron, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Bertrand","sequence":"additional","affiliation":[{"name":"Department of Cardiology, CHU A. Michallon, Joseph Fourier University, Grenoble, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Brochet","sequence":"additional","affiliation":[{"name":"APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laure","family":"Cabanes","sequence":"additional","affiliation":[{"name":"AP-HP, Department of Cardiology, Cochin Hospital, Paris-Descartes University, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erwan","family":"Donal","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Vascular Diseases, Pontchaillou Hospital, Rennes University, Rennes, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Luc","family":"Dubois-Rand\u00e9","sequence":"additional","affiliation":[{"name":"APHP, Department of Cardiology, Henri-Mondor Hospital, Paris Est 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