Study Comparing PFO Closure, Oral Blood Thinners, or Antiplatelet Therapy to Prevent Stroke in Patients Aged 60 to 80 with High-Risk Patent Foramen Ovale

What this Trial Is About

Researchers are investigating the best treatment to prevent stroke recurrence in patients aged 60 to 80 years who have a patent foramen ovale PFO with a large shunt or associated atrial septal aneurysm ASA, and have had a recent unexplained ischemic stroke. This trial aims to compare PFO closure plus antiplatelet therapy against antiplatelet therapy alone, and to evaluate oral anticoagulant therapy versus antiplatelet therapy. Prior studies showed benefits of PFO closure in patients up to 60 years old, but the best approach in older patients remains unclear. Participants are randomly assigned to one of three groups antiplatelet therapy alone aspirin or clopidogrel, oral anticoagulant therapy apixaban, dabigatran, or rivaroxaban, or PFO closure followed by dual antiplatelet therapy for 3 months then single antiplatelet therapy. The study is designed as a randomized controlled trial with single blinding and includes long-term follow-up to assess stroke recurrence and other outcomes. During the study, participants will be monitored for up to 8 years to track time to recurrent strokes, disabling strokes, and other cardiovascular events. Quality of life will be assessed every 6 months. Safety measures include monitoring for bleeding events and procedure-related complications. Researchers will also evaluate device implantation success and incidence of atrial fibrillation. The trial includes regular assessments to ensure participant safety and study adherence.

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