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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

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

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.

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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

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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