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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how effective different treatments are in preventing future strokes in older adults who have had a specific type of stroke called a cryptogenic ischemic stroke. The study is looking at three approaches: closing a heart defect known as a patent foramen ovale (PFO) combined with a type of medication to prevent blood clots (antiplatelet therapy), using only antiplatelet therapy, or taking a different type of medication (oral anticoagulants). The goal is to see which treatment works best for preventing another stroke in patients aged 60 to 80 who have a certain size of PFO or related heart structure.

To participate in this trial, individuals must be between 60 and 80 years old and have experienced a stroke within the last six months, with no other obvious cause for it. They also need to have a PFO that meets specific criteria. Participants will receive medical care and be monitored throughout the study. It’s important to note that certain health conditions or previous treatments may exclude some individuals from joining. If you or a loved one meets these criteria and are interested in participating, it could be a chance to help advance treatment options for stroke prevention.

Gender

ALL

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 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 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.
• • Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.