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New trial tests best way to prevent second stroke in older adults with a hole in the heart

NCT ID NCT05387954

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involves 792 people aged 60-80 who had a stroke linked to a patent foramen ovale (PFO), a small hole in the heart. It compares three approaches: closing the hole with a device plus antiplatelet drugs, taking newer blood thinners (apixaban, dabigatran, or rivaroxaban), or taking standard antiplatelet therapy (aspirin or clopidogrel). The goal is to see which method best prevents another stroke over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PFO closure device (procedure) or direct-acting oral anticoagulants (apixaban, dabigatran, rivaroxaban) or antiplatelet therapy (aspirin, clopidogrel)
What this could lead to
If successful, this could show that closing the heart hole or using newer blood thinners is better than standard antiplatelet therapy for preventing another stroke in older adults with a PFO.
What could go wrong
This is a Phase 3 trial, but it is still recruiting and results are not yet available. The benefits may not outweigh the risks of the procedure or bleeding from blood thinners, and findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 792 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cryptogenic ischemic stroke Patent foramen ovale

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Hôpital Lariboisière

    RECRUITING

    Paris, 75010, France

  • CH Grenoble-Site Nord

    RECRUITING

    Grenoble, 38043, France

  • CH Orsay

    RECRUITING

    Orsay, 91400, France

  • CH Perpignan

    RECRUITING

    Perpignan, 66000, France

  • CH Sud Francilien

    RECRUITING

    Corbeil-Essonnes, 91100, France

  • CH Versailles-Hôpital Mignot

    RECRUITING

    Le Chesnay, 78150, France

  • CH Yves Le Foll

    RECRUITING

    Saint-Brieuc, 22000, France

  • CHRU La Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHRU Lille-Hôpital Salengro

    RECRUITING

    Lille, 59037, France

  • CHRU Tours- Hôpital Bretonneau

    RECRUITING

    Tours, 37000, France

  • CHU Amiens

    RECRUITING

    Amiens, 80054, France

  • CHU Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94370, France

  • CHU Bordeaux - GH Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU Carémeau

    RECRUITING

    Nîmes, 30900, France

  • CHU Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU Côte de Nacre

    RECRUITING

    Caen, 14000, France

  • CHU Dijon-Hôpital François Mitterrand

    RECRUITING

    Dijon, 21079, France

  • CHU Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CHU La Milétrie

    RECRUITING

    Poitiers, 86021, France

  • CHU Limoges - Site Dupuytren

    RECRUITING

    Limoges, 87042, France

  • CHU Nantes-Hôpital Nord Laennec

    RECRUITING

    Saint-Herblain, 44093, France

  • CHU Rennes-Hôpital Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • CHU Rouen-Hôpital Charles-Nicolle

    RECRUITING

    Rouen, 76000, France

  • CHU Saint-Etienne-Hôpital Nord

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • CHU Toulouse-Hôpital Pierre Paul Riquet

    RECRUITING

    Toulouse, 31059, France

  • CHU de Nice-Hôpital Pasteur

    RECRUITING

    Nice, 06000, France

  • Centre Hospitalier de Valenciennes

    RECRUITING

    Valenciennes, 59300, France

  • Centre Hospitalier de la Côte Basque

    RECRUITING

    Bayonne, 64100, France

  • Fondation Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

  • GHU Paris Psychiatrie et Neurosciences

    RECRUITING

    Paris, 75014, France

  • GPE Hospitalier La Rochelle-Ré-Aunis

    RECRUITING

    La Rochelle, 17000, France

  • Grand Hôpital de l'Est Francilien

    RECRUITING

    Meaux, 77140, France

  • Groupe Hospitalier Paris Saint-Joseph

    RECRUITING

    Paris, 75014, France

  • HCL-Groupement Hospitalier Lyon Est

    RECRUITING

    Bron, 69677, France

  • Hôpital Foch

    RECRUITING

    Suresnes, 92150, France

  • Hôpital Gui de Chauliac

    RECRUITING

    Montpellier, 34295, France

  • Hôpital Hautepierre

    RECRUITING

    Strasbourg, 67000, France

  • Hôpital Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Hôpital Novo

    RECRUITING

    Pontoise, 95300, France

  • Hôpital Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpital Raymond Poincaré

    RECRUITING

    Garches, 92380, France

  • Hôpital de la Timone

    RECRUITING

    Marseille, 13005, France

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