Testing heart hole closure or blood thinners after stroke in adults 60 to 80
Tests heart hole closure and blood thinners to prevent repeat stroke in adults.
Plain-language title generated from the registry record
Registry title: PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Key facts
- Where
- Amiens, Bayonne, Besançon, Bordeaux, Brest, Bron, Caen, Clermont-Ferrand, Corbeil-Essonnes, Créteil, Dijon, Garches, Grenoble, La Rochelle, Le Chesnay, Le Kremlin-Bicêtre, Lille, Limoges, Marseille, Meaux, Montpellier, Nice, Nîmes, Orsay, Paris, Perpignan, Poitiers, Pontoise, Rennes, Rouen, Saint-Brieuc, Saint-Herblain, Saint-Priest-en-Jarez, Strasbourg, Suresnes, Toulouse, Tours, and Valenciennes, FranceSee the 42 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 80 years old?
Source: NCT05387954, who can take part
Where in France
- CHU AmiensAmiens, FranceTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- Chu Jean MinjozBesançon, FranceTaking people
- CHU Bordeaux - GH PellegrinBordeaux, FranceTaking people
- CHRU La Cavale BlancheBrest, FranceTaking people
- HCL-Groupement Hospitalier Lyon EstBron, FranceTaking people
- CHU Côte de NacreCaen, FranceTaking people
- CHU Clermont-FerrandClermont-Ferrand, FranceTaking people
- CH Sud FrancilienCorbeil-Essonnes, FranceTaking people
- Hopital Henri MondorCréteil, FranceTaking people
- CHU Dijon Hôpital François MitterrandDijon, FranceTaking people
- Hôpital Raymond-PoincaréGarches, FranceTaking people
- CH Grenoble-Site NordGrenoble, FranceTaking people
- Gpe Hospitalier La Rochelle-Re-AunisLa Rochelle, FranceTaking people
- CH Versailles-Hôpital MignotLe Chesnay, FranceTaking people
- CHU BicêtreLe Kremlin-Bicêtre, FranceTaking people
- CHRU Lille-Hôpital SalengroLille, FranceTaking people
- CHU Limoges - Site DupuytrenLimoges, FranceTaking people
- Hopital de la TimoneMarseille, FranceTaking people
- Grand Hopital de l'Est FrancilienMeaux, FranceTaking people
- Hôpital Gui de ChauliacMontpellier, FranceTaking people
- CHU de Nice - Hôpital PasteurNice, FranceTaking people
- CHU CarémeauNîmes, FranceTaking people
- CH OrsayOrsay, FranceTaking people
- Aphp-Hopital LariboisiereParis, FranceTaking people
- Fondation Adolphe de RothschildParis, FranceTaking people
- GHU Paris Psychiatrie et NeurosciencesParis, FranceTaking people
- Groupe hospitalier Paris saint JosephParis, FranceTaking people
- Hopital Pitie-SalpetriereParis, FranceTaking people
- Ch PerpignanPerpignan, FranceTaking people
- CHU la MiletriePoitiers, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- CHU Rennes - Hopital PontchaillouRennes, FranceTaking people
- CHU Rouen Hopital Charles NicolleRouen, FranceTaking people
- CH Yves Le FollSaint-Brieuc, FranceTaking people
- CHU Nantes - Hopital Nord LaënnecSaint-Herblain, FranceTaking people
- CHU Saint-Etienne - Hopital NordSaint-Priest-en-Jarez, FranceTaking people
- Hopital HautepierreStrasbourg, FranceTaking people
- Hopital FochSuresnes, FranceTaking people
- CHU Toulouse - Hôpital Pierre-Paul RiquetToulouse, FranceTaking people
- CHRU Tours Hopital BretonneauTours, FranceTaking people
- Centre Hospitalier de ValenciennesValenciennes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05387954
- Record updated
- 24 March 2026
- Original description
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.Read full original descriptionShow less
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.
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.
Inclusion: 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: 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; Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance; Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes; Life expectancy < 4 years; mRS > 3; 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.