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PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
60 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
792
Start Date
2023-07-07
Completion Date
2031-07-07
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
Transcatheter PFO closure
PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel until the end of the study.
Oral Anticoagulant, Direct-Acting
Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)
Antiplatelet therapy
Patients randomized to this arm will receive antiplatelet therapy throughout the study : aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then single antiplatelet therapy by aspirin or clopidogrel
Locations (42)
CHU Amiens
Amiens, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHU Jean Minjoz
Besançon, France
CHU Bordeaux - GH Pellegrin
Bordeaux, France
CHRU La Cavale Blanche
Brest, France
HCL-Groupement Hospitalier Lyon Est
Bron, France
CHU Côte de Nacre
Caen, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CH Sud Francilien
Corbeil-Essonnes, France
Hôpital Henri Mondor
Créteil, France
CHU Dijon-Hôpital François Mitterrand
Dijon, France
Hôpital Raymond Poincaré
Garches, France
CH Grenoble-Site Nord
Grenoble, France
GPE Hospitalier La Rochelle-Ré-Aunis
La Rochelle, France
CH Versailles-Hôpital Mignot
Le Chesnay, France
CHU Bicêtre
Le Kremlin-Bicêtre, France
CHRU Lille-Hôpital Salengro
Lille, France
CHU Limoges - Site Dupuytren
Limoges, France
Hôpital de la Timone
Marseille, France
Grand Hôpital de l'Est Francilien
Meaux, France
Hôpital Gui de Chauliac
Montpellier, France
CHU de Nice-Hôpital Pasteur
Nice, France
CHU Carémeau
Nîmes, France
CH Orsay
Orsay, France
APHP Hôpital Lariboisière
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
GHU Paris Psychiatrie et Neurosciences
Paris, France
Groupe Hospitalier Paris Saint-Joseph
Paris, France
Fondation Adolphe de Rothschild
Paris, France
CH Perpignan
Perpignan, France
CHU La Milétrie
Poitiers, France
Hôpital Novo
Pontoise, France
CHU Rennes-Hôpital Pontchaillou
Rennes, France
CHU Rouen-Hôpital Charles-Nicolle
Rouen, France
CH Yves Le Foll
Saint-Brieuc, France
CHU Nantes-Hôpital Nord Laennec
Saint-Herblain, France
CHU Saint-Etienne-Hôpital Nord
Saint-Priest-en-Jarez, France
Hôpital Hautepierre
Strasbourg, France
Hôpital Foch
Suresnes, France
CHU Toulouse-Hôpital Pierre Paul Riquet
Toulouse, France
CHRU Tours- Hôpital Bretonneau
Tours, France
Centre Hospitalier de Valenciennes
Valenciennes, France