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.
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
CH Arras
RECRUITING
Arras
CHU Jean Minjoz
RECRUITING
Besançon
CHU Bordeaux - GH Pellegrin
RECRUITING
Bordeaux
CHRU La Cavale Blanche
RECRUITING
Brest
HCL-Groupement Hospitalier Lyon Est
RECRUITING
Bron
CHU Côte de Nacre
RECRUITING
Caen
CHU Clermont Ferrand
RECRUITING
Clermont-ferrand
CH Sud Francilien
RECRUITING
Corbeil-essonnes
Hôpital Henri Mondor
RECRUITING
Créteil
CHU Dijon-Hôpital François Mitterrand
RECRUITING
Dijon
CH Grenoble-Site Nord
RECRUITING
Grenoble
GPE Hospitalier La Rochelle-Ré-Aunis
RECRUITING
La Rochelle
CH Versailles-Hôpital Mignot
RECRUITING
Le Chesnay
CHU Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHRU Lille-Hôpital Salengro
RECRUITING
Lille
Hôpital de la Timone
RECRUITING
Marseille
Grand Hôpital de l'Est Francilien
RECRUITING
Meaux
Hôpital Gui de Chauliac
RECRUITING
Montpellier
CHRU Nancy-Hôpital central
RECRUITING
Nancy
CHU de Nice-Hôpital Pasteur
RECRUITING
Nice
CHU Carémeau
RECRUITING
Nîmes
CH Orsay
RECRUITING
Orsay
APHP Hôpital Bichat
RECRUITING
Paris
APHP Hôpital Lariboisière
RECRUITING
Paris
Fondation Adolphe de Rothschild
RECRUITING
Paris
GHU Paris Psychiatrie et Neurosciences
RECRUITING
Paris
Groupe Hospitalier Paris Saint-Joseph
RECRUITING
Paris
Hôpital Pitié Salpêtrière
RECRUITING
Paris
CH Perpignan
RECRUITING
Perpignan
CHU La Milétrie
RECRUITING
Poitiers
Hôpital Novo
RECRUITING
Pontoise
CHU Rennes-Hôpital Pontchaillou
RECRUITING
Rennes
CHU Rouen-Hôpital Charles-Nicolle
RECRUITING
Rouen
CH Yves Le Foll
RECRUITING
Saint-brieuc
CHU Nantes-Hôpital Nord Laennec
RECRUITING
Saint-herblain
CHU Saint-Etienne-Hôpital Nord
RECRUITING
Saint-priest-en-jarez
Hôpital Hautepierre
RECRUITING
Strasbourg
Hôpital Foch
RECRUITING
Suresnes
CHU Toulouse-Hôpital Pierre Paul Riquet
RECRUITING
Toulouse
CHRU Tours- Hôpital Bretonneau
RECRUITING
Tours
Contact Information
Primary
Carla Vandenabele
carla.vandenabele@aphp.fr
+331 44 84 57 27
Backup
Malha Berrah
malha.berrah@aphp.fr
Time Frame
Start Date:2023-07-07
Estimated Completion Date:2031-07-07
Participants
Target number of participants:792
Treatments
Active_comparator: Antiplatelet therapy
Aspirin OR clopidogrel
Experimental: Oral anticoagulants, Direct-Acting
Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)
Experimental: 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