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Comparing PFO closure and anticoagulants for stroke prevention in older patients

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.

Phase 3 Interventional Assistance Publique - Hôpitaux de Paris · NCT05387954

This study is testing whether closing a small hole in the heart combined with certain medications is better than just using medications alone to prevent strokes in older patients who are at high risk.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment792 (estimated)
Ages60 Years to 80 Years
SexAll
SponsorAssistance Publique - Hôpitaux de Paris Academic / other
Locations42 sites (Amiens and 41 other locations)
Trial IDNCT05387954 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 to 80 years who have experienced a recent ischemic stroke and have a high-risk PFO.

Not a fit: Patients with a life expectancy of less than four years or those with contraindications to the interventions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for preventing recurrent strokes in older patients with PFO.

How similar studies have performed: Previous studies have shown success with PFO closure in younger populations, but this approach in older patients is less established and represents a novel investigation.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

Amiens and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cryptogenic Ischemic StrokePatent Foramen OvaleIschemic strokeCryptogenic strokePatent foramen ovaleAtrial septal aneurysmTranscatheter PFO closureOral anticoagulants
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.