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

NCT05387954 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Cryptogenic Ischemic Stroke
  • Patent 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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Occlutech International AB

    collaborator INDUSTRY

  • Centre Hospitalier St Anne

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Louis Mas, MD · GHU Psychiatrie et Neurosciences Paris

  • Gilles Chatellier, MD · Hôpital Européen Georges-Pompidou

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2031-07-07
Completion
2031-07-07

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387954 on ClinicalTrials.gov