New trial tests best way to prevent second stroke in older adults with a hole in the heart
NCT ID NCT05387954
First seen Mar 30, 2026 · Last updated Jun 23, 2026 · Updated 16 times
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.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
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Contact
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Locations
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APHP Hôpital Lariboisière
RECRUITINGParis, 75010, France
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CH Grenoble-Site Nord
RECRUITINGGrenoble, 38043, France
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CH Orsay
RECRUITINGOrsay, 91400, France
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CH Perpignan
RECRUITINGPerpignan, 66000, France
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CH Sud Francilien
RECRUITINGCorbeil-Essonnes, 91100, France
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CH Versailles-Hôpital Mignot
RECRUITINGLe Chesnay, 78150, France
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CH Yves Le Foll
RECRUITINGSaint-Brieuc, 22000, France
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CHRU La Cavale Blanche
RECRUITINGBrest, 29200, France
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CHRU Lille-Hôpital Salengro
RECRUITINGLille, 59037, France
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CHRU Tours- Hôpital Bretonneau
RECRUITINGTours, 37000, France
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CHU Amiens
RECRUITINGAmiens, 80054, France
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CHU Bicêtre
RECRUITINGLe Kremlin-Bicêtre, 94370, France
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CHU Bordeaux - GH Pellegrin
RECRUITINGBordeaux, 33000, France
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CHU Carémeau
RECRUITINGNîmes, 30900, France
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CHU Clermont Ferrand
RECRUITINGClermont-Ferrand, 63000, France
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CHU Côte de Nacre
RECRUITINGCaen, 14000, France
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CHU Dijon-Hôpital François Mitterrand
RECRUITINGDijon, 21079, France
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CHU Jean Minjoz
RECRUITINGBesançon, 25000, France
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CHU La Milétrie
RECRUITINGPoitiers, 86021, France
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CHU Limoges - Site Dupuytren
RECRUITINGLimoges, 87042, France
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CHU Nantes-Hôpital Nord Laennec
RECRUITINGSaint-Herblain, 44093, France
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CHU Rennes-Hôpital Pontchaillou
RECRUITINGRennes, 35000, France
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CHU Rouen-Hôpital Charles-Nicolle
RECRUITINGRouen, 76000, France
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CHU Saint-Etienne-Hôpital Nord
RECRUITINGSaint-Priest-en-Jarez, 42270, France
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CHU Toulouse-Hôpital Pierre Paul Riquet
RECRUITINGToulouse, 31059, France
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CHU de Nice-Hôpital Pasteur
RECRUITINGNice, 06000, France
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Centre Hospitalier de Valenciennes
RECRUITINGValenciennes, 59300, France
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Centre Hospitalier de la Côte Basque
RECRUITINGBayonne, 64100, France
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Fondation Adolphe de Rothschild
RECRUITINGParis, 75019, France
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GHU Paris Psychiatrie et Neurosciences
RECRUITINGParis, 75014, France
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GPE Hospitalier La Rochelle-Ré-Aunis
RECRUITINGLa Rochelle, 17000, France
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Grand Hôpital de l'Est Francilien
RECRUITINGMeaux, 77140, France
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Groupe Hospitalier Paris Saint-Joseph
RECRUITINGParis, 75014, France
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HCL-Groupement Hospitalier Lyon Est
RECRUITINGBron, 69677, France
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Hôpital Foch
RECRUITINGSuresnes, 92150, France
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Hôpital Gui de Chauliac
RECRUITINGMontpellier, 34295, France
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Hôpital Hautepierre
RECRUITINGStrasbourg, 67000, France
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Hôpital Henri Mondor
RECRUITINGCréteil, 94010, France
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Hôpital Novo
RECRUITINGPontoise, 95300, France
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Hôpital Pitié Salpêtrière
RECRUITINGParis, 75013, France
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Hôpital Raymond Poincaré
RECRUITINGGarches, 92380, France
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Hôpital de la Timone
RECRUITINGMarseille, 13005, France
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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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.