PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Recruiting
Phase 3
Interventional Study
Cryptogenic Ischemic Stroke
Patent Foramen Ovale
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 60 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 792 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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.
Trial Locations
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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…
Contacts