Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
Condition: Ischemic Stroke; Patent Foramen Ovale; Atrial Septal Aneurysm; Migraine
MeSH terms: Stroke; Ischemic Stroke; Aneurysm; Foramen Ovale, Patent; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke
      than in control subjects.

      Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral
      anticoagulants, and transcatheter closure of the foramen. However, there are no published
      studies showing convincingly the superiority of any one of these strategies in preventing
      stroke recurrence.

      The aim of this randomized clinical trial is to assess whether chronic anticoagulation on the
      one hand and transcatheter on the other hand are superior to chronic antiplatelet therapy in
      preventing stroke recurrence.
    

Detailed description: 
      Secondary prevention for stroke patients with PFO is a subject of considerable debate.
      Therapeutic options include antiplatelet drugs, oral anticoagulants, and transcatheter
      closure of the foramen. There are no published studies showing convincingly the superiority
      of any one of these strategies in preventing stroke recurrence. All the therapeutic options
      have some risks and unless randomised trials can define who should be treated with what (if
      anything), and for how long, we could end up exposing patients to unnecessary complications
      of treatment.

      The primary objective of this study is to assess whether chronic anticoagulation (INR 2 to 3)
      on the one hand and endovascular treatment on the other hand are superior to chronic
      antiplatelet therapy in preventing stroke recurrence in young (16 to 60 years) patients with
      a PFO (> 30 microbubbles or associated with an atrial septal aneurysm) and an otherwise
      unexplained ischaemic stroke.

      Secondary objectives of the study are:

        -  to evaluate the safety of the three therapeutic options, in terms of major drug-,
           device- or procedure-related complications, in order to allow a benefit/risk assessment
           of each therapeutic option in this population.

        -  to assess the rate of technical success and effectiveness of endovascular procedure to
           treat PFO and ASA.
    

Intervention name(s): aspirin; Antivitamins K or rivaroxaban or dabigatran or apixaban; Devices for PFO closure
Intervention type(s): Drug; Drug; Device
Intervention description(s): during the follow up; during the follow up; endovascular treatment no longer than 21 days after the random.
Other intervention name(s): clopidogrel; combination aspirin-dipyridamole; Each device for PFO closure must have the CE mark; and be approved by the Interventional Cardiology Committee
Intervention MeSH terms: Aspirin; Dipyridamole; Rivaroxaban; Apixaban; Dabigatran; Antivitamins K; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stroke; Patent Foramen Ovale; Atrial septal aneurysm; Antiplatelet therapy; Oral anticoagulants; Transcatheter closure; Migraine