close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. |
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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 |
PMID | 27056964 |
Related Publications |
Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. |
Authors | |
Mayor MeshTerms | |
Keywords | |
Journal Title | international journal of stroke : official journal of the international stroke society |
Publication Year Start | 2016-01-01 |
%A Mas, Jean-Louis; Derumeaux, Genevi?ve; Amarenco, Pierre; Arquizan, Caroline; Aubry, Pierre; Barthelet, Martine; Bertrand, Bernard; Brochet, Eric; Cabanes, Laure; Donal, Erwan; Dubois-Rand?, Jean-Luc; Durand-Zaleski, Isabelle; Ernande, Laura; Finet, G?rard; Fraisse, Alain; Giroud, Maurice; Gu?rin, Patrice; Habib, Gilbert; Juliard, Jean-Michel; Leys, Didier; Li?vre, Michel; Lusson, Jean-Ren?; Marcon, Fran?ois; Michel, Patrick; Moulin, Thierry; Mounier-Vehier, Fran?ois; Pierard, Luc; Piot, Christophe; Rey, Christian; Rodier, Gilles; Roudaut, Raymond; Schleich, Jean-Marc; Teiger, Emmanuel; Turc, Guillaume; Vuillier, Fabrice; Weimar, Christian; Woimant, France; Chatellier, Gilles %A CLOSE investigators %T close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. %J International journal of stroke : official journal of the International Stroke Society, vol. 11, no. 6, pp. 724-732 %D 08/2016 %V 11 %N 6 %M eng %B 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 %P 724 %L 732 %Y 10.1177/1747493016643551 %W PHY %G AUTHOR %R 2016.......11..724M
@Article{Mas2016, author="Mas, Jean-Louis and Derumeaux, Genevi{\`e}ve and Amarenco, Pierre and Arquizan, Caroline and Aubry, Pierre and Barthelet, Martine and Bertrand, Bernard and Brochet, Eric and Cabanes, Laure and Donal, Erwan and Dubois-Rand{\'e}, Jean-Luc and Durand-Zaleski, Isabelle and Ernande, Laura and Finet, G{\'e}rard and Fraisse, Alain and Giroud, Maurice and Gu{\'e}rin, Patrice and Habib, Gilbert and Juliard, Jean-Michel and Leys, Didier and Li{\`e}vre, Michel and Lusson, Jean-Ren{\'e} and Marcon, Fran{\c{c}}ois and Michel, Patrick and Moulin, Thierry and Mounier-Vehier, Fran{\c{c}}ois and Pierard, Luc and Piot, Christophe and Rey, Christian and Rodier, Gilles and Roudaut, Raymond and Schleich, Jean-Marc and Teiger, Emmanuel and Turc, Guillaume and Vuillier, Fabrice and Weimar, Christian and Woimant, France and Chatellier, Gilles and {CLOSE investigators}", title="close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design.", journal="International journal of stroke : official journal of the International Stroke Society", year="2016", month="Aug", day="07", volume="11", number="6", pages="724--732", 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", issn="1747-4949", doi="10.1177/1747493016643551", url="http://www.ncbi.nlm.nih.gov/pubmed/27056964", language="eng" }
%0 Journal Article %T close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. %A Mas, Jean-Louis %A Derumeaux, Genevi?ve %A Amarenco, Pierre %A Arquizan, Caroline %A Aubry, Pierre %A Barthelet, Martine %A Bertrand, Bernard %A Brochet, Eric %A Cabanes, Laure %A Donal, Erwan %A Dubois-Rand?, Jean-Luc %A Durand-Zaleski, Isabelle %A Ernande, Laura %A Finet, G?rard %A Fraisse, Alain %A Giroud, Maurice %A Gu?rin, Patrice %A Habib, Gilbert %A Juliard, Jean-Michel %A Leys, Didier %A Li?vre, Michel %A Lusson, Jean-Ren? %A Marcon, Fran?ois %A Michel, Patrick %A Moulin, Thierry %A Mounier-Vehier, Fran?ois %A Pierard, Luc %A Piot, Christophe %A Rey, Christian %A Rodier, Gilles %A Roudaut, Raymond %A Schleich, Jean-Marc %A Teiger, Emmanuel %A Turc, Guillaume %A Vuillier, Fabrice %A Weimar, Christian %A Woimant, France %A Chatellier, Gilles %A CLOSE investigators %J International journal of stroke : official journal of the International Stroke Society %D 2016 %8 Aug 07 %V 11 %N 6 %@ 1747-4949 %G eng %F Mas2016 %X 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 %U http://dx.doi.org/10.1177/1747493016643551 %U http://www.ncbi.nlm.nih.gov/pubmed/27056964 %P 724-732
PT Journal AU Mas, J Derumeaux, G Amarenco, P Arquizan, C Aubry, P Barthelet, M Bertrand, B Brochet, E Cabanes, L Donal, E Dubois-Rand?, J Durand-Zaleski, I Ernande, L Finet, G Fraisse, A Giroud, M Gu?rin, P Habib, G Juliard, J Leys, D Li?vre, M Lusson, J Marcon, F Michel, P Moulin, T Mounier-Vehier, F Pierard, L Piot, C Rey, C Rodier, G Roudaut, R Schleich, J Teiger, E Turc, G Vuillier, F Weimar, C Woimant, F Chatellier, G AU CLOSE investigators TI close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. SO International journal of stroke : official journal of the International Stroke Society JI Int J Stroke PD Aug PY 2016 BP 724 EP 732 VL 11 IS 6 DI 10.1177/1747493016643551 LA eng AB 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 ER
PMID- 27056964 OWN - NLM STAT- In-Data-Review DA - 20160727 IS - 1747-4949 (Electronic) IS - 1747-4930 (Linking) VI - 11 IP - 6 DP - 2016 Aug TI - close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. PG - 724-32 LID - 10.1177/1747493016643551 [doi] AB - 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. CI - (c) 2016 World Stroke Organization. FAU - Mas, Jean-Louis AU - Mas JL AD - Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, Inserm 894, DHU NeuroVasc, Paris, France [email protected] FAU - Derumeaux, Genevieve AU - Derumeaux G AD - Department of Physiology, Henri Mondor Hospital, Paris Est Creteil University, Inserm 955, DHU ATVB, Creteil, France. FAU - Amarenco, Pierre AU - Amarenco P AD - APHP, Department of Neurology and Stroke Center, Bichat Hospital, Paris-Diderot University, Inserm 1148, DHU FIRE, Paris, France. FAU - Arquizan, Caroline AU - Arquizan C AD - Department of Neurology, Gui de Chauliac Hospital, Montpellier, France. FAU - Aubry, Pierre AU - Aubry P AD - APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France. FAU - Barthelet, Martine AU - Barthelet M AD - Department of Cardiovascular Investigations, Louis Pradel Hospital, Lyon University, Bron, France. FAU - Bertrand, Bernard AU - Bertrand B AD - Department of Cardiology, CHU A. Michallon, Joseph Fourier University, Grenoble, France. FAU - Brochet, Eric AU - Brochet E AD - APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France. FAU - Cabanes, Laure AU - Cabanes L AD - AP-HP, Department of Cardiology, Cochin Hospital, Paris-Descartes University, Paris, France. FAU - Donal, Erwan AU - Donal E AD - Department of Cardiology and Vascular Diseases, Pontchaillou Hospital, Rennes University, Rennes, France. FAU - Dubois-Rande, Jean-Luc AU - Dubois-Rande JL AD - APHP, Department of Cardiology, Henri-Mondor Hospital, Paris Est Creteil University, Inserm 955, DHU ATVB, Creteil, France. FAU - Durand-Zaleski, Isabelle AU - Durand-Zaleski I AD - AP-HP, Department of Public Health, Henri Mondor Hospital, Paris Est Creteil University, Creteil, France. FAU - Ernande, Laura AU - Ernande L AD - Department of Physiology, Henri Mondor Hospital, Paris Est Creteil University, Inserm 955, DHU ATVB, Creteil, France. FAU - Finet, Gerard AU - Finet G AD - Department of Cardiology, Cardiovascular Hospital, Claude Bernard University, Inserm 1060, Lyon, France. FAU - Fraisse, Alain AU - Fraisse A AD - Department of Pediatric Cardiology, La Timone Hospital, Aix-Marseille Universite, Marseille, France. FAU - Giroud, Maurice AU - Giroud M AD - Department of Neurology, CHU Dijon, Bourgogne University, Dijon Stroke Registry, Dijon France. FAU - Guerin, Patrice AU - Guerin P AD - Department of Cardiology, Institut du Thorax, CHU Nantes, Nantes, France. FAU - Habib, Gilbert AU - Habib G AD - Department of Cardiology, La Timone Hospital, Aix-Marseille Universite, Marseille France. FAU - Juliard, Jean-Michel AU - Juliard JM AD - APHP, Department of Cardiology, Bichat Hospital, Paris Diderot University, Inserm 1148, DHU FIRE, Paris, France. FAU - Leys, Didier AU - Leys D AD - Department of Neurology and Stroke Unit, Roger Salengro Hospital, Lille 2 University, Inserm 1171, Lille, France. FAU - Lievre, Michel AU - Lievre M AD - UMR CNRS 5558, Lyon 1 University, Lyon, France. FAU - Lusson, Jean-Rene AU - Lusson JR AD - Department of Cardiology and Vascular Diseases, Gabriel Montpied Hospital, Auvergne University, UMR 6284 Clermont-Ferrand, France. FAU - Marcon, Francois AU - Marcon F AD - Department of Cardiovascular Diseases, Pediatric Cardiology Unit, Nancy University, Nancy, France. FAU - Michel, Patrick AU - Michel P AD - Stroke Center, Department of Neurology, Centre Hospitalier Universitaire Vaudois and Lausanne University, Lausanne, Switzerland. FAU - Moulin, Thierry AU - Moulin T AD - Department of Neurology, CHU Besancon, Franche-Comte University, CIC 1431, Besancon, France. FAU - Mounier-Vehier, Francois AU - Mounier-Vehier F AD - Department of Neurology, Doctor Schaffner Hospital, Lens, France. FAU - Pierard, Luc AU - Pierard L AD - Department of Cardiology, Sart Tilman Hospital, Liege University, Liege, Belgium. FAU - Piot, Christophe AU - Piot C AD - Department of Interventional Cardiology, Clinique du Millenaire, Montpellier University, UMR 5203, Montpellier, France. FAU - Rey, Christian AU - Rey C AD - Department of Pediatric Cardiology, Cardiology Hospital, Lille 2 University, Lille, France. FAU - Rodier, Gilles AU - Rodier G AD - Department of Neurology, Annecy-Genevois Hospital, Annecy, France. FAU - Roudaut, Raymond AU - Roudaut R AD - Department of Cardiology and Vascular Diseases, Haut Leveque Hospital, Bordeaux University, Bordeaux, France. FAU - Schleich, Jean-Marc AU - Schleich JM AD - Department of Cardiology and Vascular Diseases, Pontchaillou Hospital, Rennes University, Rennes, France. FAU - Teiger, Emmanuel AU - Teiger E AD - Department of Physiology, Henri Mondor Hospital, Paris Est Creteil University, Inserm 955, DHU ATVB, Creteil, France. FAU - Turc, Guillaume AU - Turc G AD - Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, Inserm 894, DHU NeuroVasc, Paris, France. FAU - Vuillier, Fabrice AU - Vuillier F AD - Department of Neurology, CHU Besancon, Franche-Comte University, CIC 1431, Besancon, France. FAU - Weimar, Christian AU - Weimar C AD - Department of Neurology, University Hospital, University of Duisburg-Essen, Essen, Germany. FAU - Woimant, France AU - Woimant F AD - APHP, Department of Neurology, Lariboisiere Hospital, Agence Regionale de Sante Ile-de-France, Paris, France. FAU - Chatellier, Gilles AU - Chatellier G AD - APHP, Epidemiology and Clinical Research Unit, Georges Pompidou European hospital, Paris Descartes University, Paris, France. CN - CLOSE investigators LA - eng PT - Journal Article DEP - 20160407 PL - United States TA - Int J Stroke JT - International journal of stroke : official journal of the International Stroke Society JID - 101274068 SB - IM OTO - NOTNLM OT - Ischaemic stroke OT - antiplatelet therapy OT - oral anticoagulants OT - patent foramen ovale OT - transcatheter PFO closure EDAT- 2016/04/09 06:00 MHDA- 2016/04/09 06:00 CRDT- 2016/04/09 06:00 PHST- 2016/01/14 [received] PHST- 2016/03/13 [accepted] PHST- 2016/04/07 [aheadofprint] AID - 1747493016643551 [pii] AID - 10.1177/1747493016643551 [doi] PST - ppublish SO - Int J Stroke. 2016 Aug;11(6):724-32. doi: 10.1177/1747493016643551. Epub 2016 Apr 7.
TY - JOUR AU - Mas, Jean-Louis AU - Derumeaux, Genevi?ve AU - Amarenco, Pierre AU - Arquizan, Caroline AU - Aubry, Pierre AU - Barthelet, Martine AU - Bertrand, Bernard AU - Brochet, Eric AU - Cabanes, Laure AU - Donal, Erwan AU - Dubois-Rand?, Jean-Luc AU - Durand-Zaleski, Isabelle AU - Ernande, Laura AU - Finet, G?rard AU - Fraisse, Alain AU - Giroud, Maurice AU - Gu?rin, Patrice AU - Habib, Gilbert AU - Juliard, Jean-Michel AU - Leys, Didier AU - Li?vre, Michel AU - Lusson, Jean-Ren? AU - Marcon, Fran?ois AU - Michel, Patrick AU - Moulin, Thierry AU - Mounier-Vehier, Fran?ois AU - Pierard, Luc AU - Piot, Christophe AU - Rey, Christian AU - Rodier, Gilles AU - Roudaut, Raymond AU - Schleich, Jean-Marc AU - Teiger, Emmanuel AU - Turc, Guillaume AU - Vuillier, Fabrice AU - Weimar, Christian AU - Woimant, France AU - Chatellier, Gilles AU - CLOSE investigators PY - 2016/Aug/07 TI - close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. T2 - Int J Stroke JO - International journal of stroke : official journal of the International Stroke Society SP - 724 EP - 732 VL - 11 IS - 6 N2 - 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 SN - 1747-4949 UR - http://dx.doi.org/10.1177/1747493016643551 UR - http://www.ncbi.nlm.nih.gov/pubmed/27056964 ID - Mas2016 ER -
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