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RECRUITINGPhase 3INTERVENTIONAL

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

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form form. Patient under tutorship, curatorship, or legal protection. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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. 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 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.

Treatments Being Tested

PROCEDURE

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.

DRUG

Oral Anticoagulant, Direct-Acting

Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

DRUG

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 (20)

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