CLOSE 2007.

Trial name or title	Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE)
Methods	Randomized, open label, parallel assignment study
Participants	Young (16 to 60 years) patients with a PFO (> 30 microbubbles or associated with an atrial septal aneurysm) and an otherwise unexplained recent ischemic stroke (≤ 6 months) Estimated enrolment: 900
Interventions	Drug: aspirin or anticoagulant Device: devices for PFO closure
Outcomes	Primary outcome measures: stroke (fatal or non‐fatal) during the follow‐up (between 3 or 5 years) Secondary outcome measures: disabling stroke; ischemic stroke; cerebral hemorrhage; TIA, or systemic embolism; death (all causes); vascular death; moderate to severe bleeding complications during the follow‐up; procedural or device complications within 30 days
Starting date	2007
Contact information	Jean‐Louis Mas    +33145658284   jl.mas@ch‐sainte‐anne.fr
Notes	ClinicalTrials.gov: NCT00562289