Status:
RECRUITING
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
W.L.Gore & Associates
Conditions:
Cryptogenic Ischemic Stroke
Patent Foramen Ovale
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
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 recurrenc...
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...
Eligibility Criteria
Inclusion
- 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 opacification of the right atrium, detected 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 with ASA on transoesophageal echocardiography: excursion \>10 mm
- Affiliation to a French Health Insurance system. Informed consent.
Exclusion
- 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.
- Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 7 2031
Estimated Enrollment :
792 Patients enrolled
Trial Details
Trial ID
NCT05387954
Start Date
July 7 2023
End Date
July 7 2031
Last Update
December 19 2024
Active Locations (41)
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1
CHU Amiens
Amiens, France, 80054
2
CH Arras
Arras, France, 62022
3
CHU Jean Minjoz
Besançon, France, 25000
4
CHU Bordeaux - GH Pellegrin
Bordeaux, France, 33000