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.
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).
PFO with large shunt (> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either 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.
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.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ministry of Health, France
Collaborator
W.L.Gore & Associates
Collaborator
Abbott
Collaborator
Occlutech International AB
Collaborator
Centre Hospitalier St Anne
Collaborator