NCT05387954 - PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years | Biotech Hunter

Enrollment

792

Participants

Timeline

Start Date

July 7, 2023

Primary Completion Date

July 7, 2031

Study Completion Date

July 7, 2031

Conditions

Cryptogenic Ischemic StrokePatent Foramen Ovale

Interventions

PROCEDURE

Transcatheter PFO closure

PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel until the end of the study.

DRUG

Oral Anticoagulant, Direct-Acting

Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

DRUG

Antiplatelet therapy

Patients randomized to this arm will receive antiplatelet therapy throughout the study : aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then single antiplatelet therapy by aspirin or clopidogrel

Trial Locations (41)

13005

RECRUITING

Hôpital de la Timone, Marseille

14000

RECRUITING

CHU Côte de Nacre, Caen

17000

RECRUITING

GPE Hospitalier La Rochelle-Ré-Aunis, La Rochelle

21079

RECRUITING

CHU Dijon-Hôpital François Mitterrand, Dijon

22000

RECRUITING

CH Yves Le Foll, Saint-Brieuc

25000

RECRUITING

CHU Jean Minjoz, Besançon

29200

RECRUITING

CHRU La Cavale Blanche, Brest

30900

RECRUITING

CHU Carémeau, Nîmes

31059

RECRUITING

CHU Toulouse-Hôpital Pierre Paul Riquet, Toulouse

33000

RECRUITING

CHU Bordeaux - GH Pellegrin, Bordeaux

34295

RECRUITING

Hôpital Gui de Chauliac, Montpellier

35000

RECRUITING

CHU Rennes-Hôpital Pontchaillou, Rennes

37000

RECRUITING

CHRU Tours- Hôpital Bretonneau, Tours

38043

RECRUITING

CH Grenoble-Site Nord, Grenoble

42270

RECRUITING

CHU Saint-Etienne-Hôpital Nord, Saint-Priest-en-Jarez

44093

RECRUITING

CHU Nantes-Hôpital Nord Laennec, Saint-Herblain

54035

RECRUITING

CHRU Nancy-Hôpital central, Nancy

59037

RECRUITING

CHRU Lille-Hôpital Salengro, Lille

62022

RECRUITING

CH Arras, Arras

63000

RECRUITING

CHU Clermont Ferrand, Clermont-Ferrand

66000

RECRUITING

CH Perpignan, Perpignan

67000

RECRUITING

Hôpital Hautepierre, Strasbourg

69677

RECRUITING

HCL-Groupement Hospitalier Lyon Est, Bron

75010

RECRUITING

APHP Hôpital Lariboisière, Paris

75013

RECRUITING

Hôpital Pitié Salpêtrière, Paris

75014

RECRUITING

GHU Paris Psychiatrie et Neurosciences, Paris

RECRUITING

Groupe Hospitalier Paris Saint-Joseph, Paris

75018

RECRUITING

APHP Hôpital Bichat, Paris

75019

RECRUITING

Fondation Adolphe de Rothschild, Paris

76000

RECRUITING

CHU Rouen-Hôpital Charles-Nicolle, Rouen

77140

RECRUITING

Grand Hôpital de l'Est Francilien, Meaux

78150

RECRUITING

CH Versailles-Hôpital Mignot, Le Chesnay

80054

RECRUITING

CHU Amiens, Amiens

86021

RECRUITING

CHU La Milétrie, Poitiers

91100

RECRUITING

CH Sud Francilien, Corbeil-Essonnes

91400

RECRUITING

CH Orsay, Orsay

92150

RECRUITING

Hôpital Foch, Suresnes

94010

RECRUITING

Hôpital Henri Mondor, Créteil

94370

RECRUITING

CHU Bicêtre, Le Kremlin-Bicêtre

95300

RECRUITING

Hôpital Novo, Pontoise

06000

RECRUITING

CHU de Nice-Hôpital Pasteur, Nice