Comparing PFO closure and anticoagulants for stroke prevention in older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of transcatheter closure of patent foramen ovale (PFO) combined with antiplatelet therapy versus antiplatelet therapy alone, as well as the effectiveness of oral anticoagulants compared to antiplatelet therapy in preventing recurrent strokes in patients aged 60 to 80 years with a high-risk PFO. The study aims to address a gap in knowledge regarding optimal treatment strategies for older patients who have experienced a cryptogenic ischemic stroke. Participants will be closely monitored for stroke recurrence following the interventions. The trial builds on previous findings that suggest PFO closure may reduce stroke risk in younger patients but seeks to clarify the best approach for older individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Amiens
  Amiens, France Recruiting
• Centre Hospitalier de la Côte Basque
  Bayonne, France Recruiting
• CHU Jean Minjoz
  Besançon, France Recruiting
• CHU Bordeaux - GH Pellegrin
  Bordeaux, France Recruiting
• CHRU La Cavale Blanche
  Brest, France Recruiting
• HCL-Groupement Hospitalier Lyon Est
  Bron, France Recruiting

Study contacts

• Principal investigator: Jean-Louis Mas, MD — GHU Psychiatrie et Neurosciences Paris
• Study coordinator: Carla Vandenabele
• Email: carla.vandenabele@aphp.fr
• Phone: +331 44 84 57 27

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

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• P3 Occluder System for closing a heart opening (PFO) after stroke

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• Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA

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• Advanced heart MRI and CT to find hidden clots after cryptogenic stroke in people with left ventricular disease

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  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07298122

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.