PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

Recruiting now · Phase 3

Conditions studied: Cryptogenic Ischemic Stroke, Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT05387954

Run by

Assistance Publique - Hôpitaux de Paris

People needed

792

Starts

2023-07-07

Expected to finish

2031-07-07

Last updated by the study team

2026-03-24

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.
• PFO associated with an ASA on transoesophageal echocardiography: excursion >10 mm
• Affiliation to a French Health Insurance system. Informed consent.

You may not qualify if…

• 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.
• PFO associated with an atrial septal defect (ASD) requiring closure (significant shunt with impact on the right cavities, elevation of pulmonary pressures or QP/QS>2)
• Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.

Where it is running

• CHU Amiens — Amiens, France (enrolling)
• Centre Hospitalier de la Côte Basque — Bayonne, France (enrolling)
• CHU Jean Minjoz — Besançon, France (enrolling)
• CHU Bordeaux - GH Pellegrin — Bordeaux, France (enrolling)
• CHRU La Cavale Blanche — Brest, France (enrolling)
• HCL-Groupement Hospitalier Lyon Est — Bron, France (enrolling)
• CHU Côte de Nacre — Caen, France (enrolling)
• CHU Clermont Ferrand — Clermont-Ferrand, France (enrolling)
• CH Sud Francilien — Corbeil-Essonnes, France (enrolling)
• Hôpital Henri Mondor — Créteil, France (enrolling)
• CHU Dijon-Hôpital François Mitterrand — Dijon, France (enrolling)
• Hôpital Raymond Poincaré — Garches, France (enrolling)
• CH Grenoble-Site Nord — Grenoble, France (enrolling)
• GPE Hospitalier La Rochelle-Ré-Aunis — La Rochelle, France (enrolling)
• CH Versailles-Hôpital Mignot — Le Chesnay, France (enrolling)
• CHU Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• CHRU Lille-Hôpital Salengro — Lille, France (enrolling)
• CHU Limoges - Site Dupuytren — Limoges, France (enrolling)
• Hôpital de la Timone — Marseille, France (enrolling)
• Grand Hôpital de l'Est Francilien — Meaux, France (enrolling)
• Hôpital Gui de Chauliac — Montpellier, France (enrolling)
• CHU de Nice-Hôpital Pasteur — Nice, France (enrolling)
• CHU Carémeau — Nîmes, France (enrolling)
• CH Orsay — Orsay, France (enrolling)
• APHP Hôpital Lariboisière — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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