Informations générales (source: ClinicalTrials.gov)
Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial. (CLOSE-2)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2023
juillet 2031
05 avril 2025
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet
therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy
to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt
(> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise
unexplained ischemic stroke.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| HOPITAL FOCH | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | MAS Jean-louis | 18/04/2025 07:55:47 | Contacter | ||
| HOPITAL NOVO | NICLOT Philippe | 14/02/2025 09:03:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Didier SMADJA, MD | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Fernando Pico, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP Hôpital Lariboisière - 75010 - Paris - France | Peggy Reiner, MD | Contact (sur clinicalTrials) | |||
| CH Arras - 62022 - Arras - France | Patrick Le-Coz, MD | Contact (sur clinicalTrials) | |||
| CH Grenoble-Site Nord - 38043 - Grenoble - France | Isabelle Favre Wiki, MD | Contact (sur clinicalTrials) | |||
| CH Orsay - 91400 - Orsay - France | François Lun, MD | Contact (sur clinicalTrials) | |||
| CH Perpignan - 66000 - Perpignan - France | Denis Sablot, MD | Contact (sur clinicalTrials) | |||
| CH Yves Le Foll - 22000 - Saint Brieuc - France | Grégory Couvreur, MD | Contact (sur clinicalTrials) | |||
| CHRU La Cavale Blanche - 29200 - Brest - France | Serge Timsit, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille-Hôpital Salengro - 59037 - Lille - France | Nelly Dequatre, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy-Hôpital central - 54035 - Nancy - France | Sébastien Richard, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours- Hôpital Bretonneau - 37000 - Tours - France | Marco Pasi, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens - 80054 - Amiens - France | Sandrine Canaple, MD | Contact (sur clinicalTrials) | |||
| CHU Bicêtre - 94370 - Le Kremlin-Bicetre - France | Christian Denier, MD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - GH Pellegrin - 33000 - Bordeaux - France | Pauline Renou, MD | Contact (sur clinicalTrials) | |||
| CHU Carémeau - 30900 - Nîmes - France | Anne Wacongne, MD | Contact (sur clinicalTrials) | |||
| CHU Clermont Ferrand - 63000 - Clermont-Ferrand - France | Anna Ferrier, MD | Contact (sur clinicalTrials) | |||
| CHU Côte de Nacre - 14000 - Caen - France | Marion Boulanger, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice-Hôpital Pasteur - 06000 - Nice - France | Marie-Hélène Mahagne, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon-Hôpital François Mitterrand - 21079 - Dijon - France | Yannick Béjot, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz - 25000 - Besançon - France | Fabrice Vuillier, MD | Contact (sur clinicalTrials) | |||
| CHU La Milétrie - 86021 - Poitiers - France | Nathalie Nasr, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes-Hôpital Nord Laennec - 44093 - Saint Herblain - France | Benoit Guillon, MD | Contact (sur clinicalTrials) | |||
| CHU Rennes-Hôpital Pontchaillou - 35000 - Rennes - France | Stéphane Vannier, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen-Hôpital Charles-Nicolle - 76000 - Rouen - France | Evelyne Guegan-Massardier, MD | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne-Hôpital Nord - 42270 - Saint-Priest en Jarez - France | Pierre Garnier, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse-Hôpital Pierre Paul Riquet - 31059 - Toulouse - France | Nicolas Raposo, MD | Contact (sur clinicalTrials) | |||
| GHU Paris Psychiatrie et Neurosciences - 75014 - Paris - France | Guillaume Turc, MD | Contact (sur clinicalTrials) | |||
| GPE Hospitalier La Rochelle-Ré-Aunis - 17000 - La Rochelle - France | Gaëlle GODENECHE, MD | Contact (sur clinicalTrials) | |||
| Grand Hôpital de l'Est Francilien - 77140 - Meaux - France | Alain Ameri, MD | Contact (sur clinicalTrials) | |||
| HCL-Groupement Hospitalier Lyon Est - 69677 - Bron - France | Laurent Derex, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - 13005 - Marseille - France | Emmanuelle Robinet Borgomano, MD | Contact (sur clinicalTrials) | |||
| Hôpital Gui de Chauliac - 34295 - Montpellier - France | Caroline Arquizan, MD | Contact (sur clinicalTrials) | |||
| Hôpital Hautepierre - 67000 - Strasbourg - France | Valérie Wolff, MD | Contact (sur clinicalTrials) | |||
| Hôpital Pitié Salpêtrière - 75013 - Paris - France | Sonia Alamowitch, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Man or woman aged 60 to 80 years.
- Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of
symptom duration.
- Absence of a more probable cause of stroke than PFO after a standardized etiological
work-up (see addenda).
- Presence of a PFO with at least 1 of the 2 following characteristics:
- PFO with large shunt > 20 microbubbles appearing in the left atrium during at
least one of the 3 cardiac cycles after opacification of the right atrium,
detected spontaneously or during provocative manoeuvers, on contrast
transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis
of PFO by contrast TEE must be confirmed by contrast TOE showing a
right-to-left passage of the contrast material across the PFO.
- PFO with ASA on transoesophageal echocardiography: excursion >10 mm
- Affiliation to a French Health Insurance system. Informed consent.
- Man or woman aged 60 to 80 years.
- Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of
symptom duration.
- Absence of a more probable cause of stroke than PFO after a standardized etiological
work-up (see addenda).
- Presence of a PFO with at least 1 of the 2 following characteristics:
- PFO with large shunt > 20 microbubbles appearing in the left atrium during at
least one of the 3 cardiac cycles after opacification of the right atrium,
detected spontaneously or during provocative manoeuvers, on contrast
transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis
of PFO by contrast TEE must be confirmed by contrast TOE showing a
right-to-left passage of the contrast material across the PFO.
- PFO with ASA on transoesophageal echocardiography: excursion >10 mm
- Affiliation to a French Health Insurance system. Informed consent.
- Life expectancy < 4 years.
- Contraindication to both experimental treatments (PFO closure, oral anticoagulant
therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).
- Indication to long-term anticoagulant therapy.
- mRS >= 3.
- Presence of other medical conditions that would lead to inability to complete the
study or interfere with the assessment of outcomes.
- Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible
follow-up or poor compliance.
- Patient unable to understand the informed consent form. Patient under tutorship,
curatorship, or legal protection.