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ClinicalTrials.gov ID

NCT05387954

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

792Estimated

Last Update Posted

Mar 24, 2026Actual

Start Date

Jul 7, 2023Actual

Primary Completion Date

Jul 7, 2031Estimated

Completion Date

Jul 7, 2031Estimated

Official Title

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.

Brief 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.

Detailed Description

The CLOSE trial (NCT00562289, NEJM 2017) has unambiguously demonstrated the superiority of patent foramen ovale (PFO) closure over antiplatelet therapy alone in patients aged up to 60 years with a PFO associated with an atrial septal aneurysm (ASA) or a large right-to-left shunt (so-called "high-risk PFO"), and an otherwise unexplained ischemic stroke. Oral anticoagulant therapy is also a logical approach assuming that PFO-related strokes are due to paradoxical embolism which implies a venous source of embolism, or to direct embolization of a thrombus formed at the atrial level. The CLOSE trial also suggested that oral anticoagulants might reduce stroke recurrence compared to aspirin.

There is accumulating evidence that presence of a PFO is significantly associated with cryptogenic stroke in patients over 60 years. Cryptogenic ischemic strokes represent about one third of all ischemic strokes in patients older than 60 years. However, the optimal therapeutic strategy in patients older than 60 years with a PFO and an otherwise unexplained ischemic stroke is unknown, because these patients were excluded from randomized trials.

The hypothesis tested in this trial is that transcatheter PFO closure plus long-term antiplatelet therapy is superior to antiplatelet therapy alone and that oral anticoagulant therapy is superior to antiplatelet therapy to prevent recurrent stroke in patients aged 60 to 80 years who have a high-risk PFO and a recent otherwise unexplained ischemic stroke.

• Cryptogenic Ischemic Stroke
• Patent Foramen Ovale

• Transcatheter PFO closure
• Oral Anticoagulant, Direct-Acting
• Antiplatelet therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Ministry of Health, FranceOTHER_GOV

W.L.Gore & AssociatesINDUSTRY

AbbottINDUSTRY

Occlutech International ABINDUSTRY

Centre Hospitalier St AnneOTHER

f.lun@ghne.fr01 69 29 76 01

philippe.niclot@ght-novo.fr01 30 75 40 40