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

• Status: Not yet recruiting
• Trial end date: 2030-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Abbott; Centre Hospitalier St Anne; Gore; Ministry of Health, France; Occlutech International AB
• Treatments: Anticoagulants; Factor Xa Inhibitors

Criteria

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 inthe left atrium within 3 cardiac cycles after opacification of the right atrium) detected spontaneously or during provocative maneuvers,

• PFO with ASA on transesophageal echocardiography (TOE): base of aneurysm >= 15mm and excursion >10 mm.

• Affiliation to a French Health Insurance system. Informed consent.

Exclusion Criteria:

• Life expectancy < 4 years.

• Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 19.5). 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.