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.
Assistance Publique - Hôpitaux de Paris
792 participants
Jul 7, 2023
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
Inclusion Criteria7
- 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 Criteria8
- 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.
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Interventions
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.
Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)
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)
View Full Details on ClinicalTrials.gov
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NCT05387954