Table 2.

Ongoing randomized studies

Study	Estimated number	Inclusion criteria	Intervention	Comparator	Primary outcome
CLOSE[48]	900	16-60 years of age Recent (≤6 months) ischemic CS Presence of PFO (RLS >30 microbubbles and/or associated ASA	PFO closure device not specified VKAs (INR 2-3)	Antiplatelets (aspirin, clopidogrel, aspirin with dipyridamole)	Stroke (fatal and nonfatal) at 3-5 years
DEFENSE-PFO[49]	210	18-80 years of age CS within 3 months High-risk PFO	Amplatzer PFO Occluder	Antiplatelet or anticoagulant therapy	Recurrence of nonfatal stroke/vascular death/TIMI-major bleeding at 2 years
Gore-REDUCE[50]	664	18-80 years of age CS or TIA of presumed embolic infarction within 180 days Presence of a PFO	GORE HELEX Septal Occluder or GORE Septal Occluder	Antiplatelet medical therapy	Freedom from recurrent ischemic stroke or TIA at 24 months

CS = Cryptogenic stroke, INR = International normalized ratio, PFO = Patent foramen ovale, RLS = Right-to-left shunt, TIA = Transient ischemic attack, TIMI = Thrombolysis in myocardial infarction, VKA = Vitamin K antagonist, ASA = Atrial septal aneurysm, High-risk PFO = PFO size ≥2 mm, or ASA or hypermobility