RecruitingPhase 3NCT05387954

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

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.


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

792 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antiplatelet therapy, a drug called Oral Anticoagulant, Direct-Acting, and others for people with cryptogenic ischemic stroke and patent foramen ovale. The study is currently recruiting participants at 42 locations. People eligible for this study include aged 60 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETranscatheter 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.

DRUGOral Anticoagulant, Direct-Acting

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

DRUGAntiplatelet 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


Locations(42)

CHU Amiens

Amiens, France

Centre Hospitalier de la Côte Basque

Bayonne, France

CHU Jean Minjoz

Besançon, France

CHU Bordeaux - GH Pellegrin

Bordeaux, France

CHRU La Cavale Blanche

Brest, France

HCL-Groupement Hospitalier Lyon Est

Bron, France

CHU Côte de Nacre

Caen, France

CHU Clermont Ferrand

Clermont-Ferrand, France

CH Sud Francilien

Corbeil-Essonnes, France

Hôpital Henri Mondor

Créteil, France

CHU Dijon-Hôpital François Mitterrand

Dijon, France

Hôpital Raymond Poincaré

Garches, France

CH Grenoble-Site Nord

Grenoble, France

GPE Hospitalier La Rochelle-Ré-Aunis

La Rochelle, France

CH Versailles-Hôpital Mignot

Le Chesnay, France

CHU Bicêtre

Le Kremlin-Bicêtre, France

CHRU Lille-Hôpital Salengro

Lille, France

CHU Limoges - Site Dupuytren

Limoges, France

Hôpital de la Timone

Marseille, France

Grand Hôpital de l'Est Francilien

Meaux, France

Hôpital Gui de Chauliac

Montpellier, France

CHU de Nice-Hôpital Pasteur

Nice, France

CHU Carémeau

Nîmes, France

CH Orsay

Orsay, France

APHP Hôpital Lariboisière

Paris, France

Hôpital Pitié Salpêtrière

Paris, France

GHU Paris Psychiatrie et Neurosciences

Paris, France

Groupe Hospitalier Paris Saint-Joseph

Paris, France

Fondation Adolphe de Rothschild

Paris, France

CH Perpignan

Perpignan, France

CHU La Milétrie

Poitiers, France

Hôpital Novo

Pontoise, France

CHU Rennes-Hôpital Pontchaillou

Rennes, France

CHU Rouen-Hôpital Charles-Nicolle

Rouen, France

CH Yves Le Foll

Saint-Brieuc, France

CHU Nantes-Hôpital Nord Laennec

Saint-Herblain, France

CHU Saint-Etienne-Hôpital Nord

Saint-Priest-en-Jarez, France

Hôpital Hautepierre

Strasbourg, France

Hôpital Foch

Suresnes, France

CHU Toulouse-Hôpital Pierre Paul Riquet

Toulouse, France

CHRU Tours- Hôpital Bretonneau

Tours, France

Centre Hospitalier de Valenciennes

Valenciennes, France

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NCT05387954


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