title: Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design.
abstract: BACKGROUND
  Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events.
  
  
  METHODS
  The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism.
  
  
  CONCLUSIONS
  patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).
authors.affiliation: Cardiology Department, Bern University Hospital, Bern, Switzerland.
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Henning R
authors.initials: HR
authors.lastname: Andersen
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Antony S
authors.initials: AS
authors.lastname: Walton
authors.forename: Andreas
authors.initials: A
authors.lastname: Wahl
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001315:Australia; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control*; D005060:Europe; D054092:Foramen Ovale, Patent / Q000150:complications / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D055502:Secondary Prevention; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors