Actively Recruiting
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-24
792
Participants Needed
42
Research Sites
417 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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.
You will not qualify if you...
- 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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Trial Site Locations
Total: 42 locations
1
CHU Amiens
Amiens, France, 80054
Actively Recruiting
2
Centre Hospitalier de la Côte Basque
Bayonne, France, 64100
Actively Recruiting
3
CHU Jean Minjoz
Besançon, France, 25000
Actively Recruiting
4
CHU Bordeaux - GH Pellegrin
Bordeaux, France, 33000
Actively Recruiting
5
CHRU La Cavale Blanche
Brest, France, 29200
Actively Recruiting
6
HCL-Groupement Hospitalier Lyon Est
Bron, France, 69677
Actively Recruiting
7
CHU Côte de Nacre
Caen, France, 14000
Actively Recruiting
8
CHU Clermont Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
9
CH Sud Francilien
Corbeil-Essonnes, France, 91100
Actively Recruiting
10
Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
11
CHU Dijon-Hôpital François Mitterrand
Dijon, France, 21079
Actively Recruiting
12
Hôpital Raymond Poincaré
Garches, France, 92380
Actively Recruiting
13
CH Grenoble-Site Nord
Grenoble, France, 38043
Actively Recruiting
14
GPE Hospitalier La Rochelle-Ré-Aunis
La Rochelle, France, 17000
Actively Recruiting
15
CH Versailles-Hôpital Mignot
Le Chesnay, France, 78150
Actively Recruiting
16
CHU Bicêtre
Le Kremlin-Bicêtre, France, 94370
Actively Recruiting
17
CHRU Lille-Hôpital Salengro
Lille, France, 59037
Actively Recruiting
18
CHU Limoges - Site Dupuytren
Limoges, France, 87042
Actively Recruiting
19
Hôpital de la Timone
Marseille, France, 13005
Actively Recruiting
20
Grand Hôpital de l'Est Francilien
Meaux, France, 77140
Actively Recruiting
21
Hôpital Gui de Chauliac
Montpellier, France, 34295
Actively Recruiting
22
CHU de Nice-Hôpital Pasteur
Nice, France, 06000
Actively Recruiting
23
CHU Carémeau
Nîmes, France, 30900
Actively Recruiting
24
CH Orsay
Orsay, France, 91400
Actively Recruiting
25
APHP Hôpital Lariboisière
Paris, France, 75010
Actively Recruiting
26
Hôpital Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
27
GHU Paris Psychiatrie et Neurosciences
Paris, France, 75014
Actively Recruiting
28
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Actively Recruiting
29
Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
30
CH Perpignan
Perpignan, France, 66000
Actively Recruiting
31
CHU La Milétrie
Poitiers, France, 86021
Actively Recruiting
32
Hôpital Novo
Pontoise, France, 95300
Actively Recruiting
33
CHU Rennes-Hôpital Pontchaillou
Rennes, France, 35000
Actively Recruiting
34
CHU Rouen-Hôpital Charles-Nicolle
Rouen, France, 76000
Actively Recruiting
35
CH Yves Le Foll
Saint-Brieuc, France, 22000
Actively Recruiting
36
CHU Nantes-Hôpital Nord Laennec
Saint-Herblain, France, 44093
Actively Recruiting
37
CHU Saint-Etienne-Hôpital Nord
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
38
Hôpital Hautepierre
Strasbourg, France, 67000
Actively Recruiting
39
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
40
CHU Toulouse-Hôpital Pierre Paul Riquet
Toulouse, France, 31059
Actively Recruiting
41
CHRU Tours- Hôpital Bretonneau
Tours, France, 37000
Actively Recruiting
42
Centre Hospitalier de Valenciennes
Valenciennes, France, 59300
Actively Recruiting
Research Team
C
Carla Vandenabele
CONTACT
M
Malha Berrah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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