PC-Trial
Patent foramen ovale and Cryptogenic embolism
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Status:
Website for PC-Trial states recruitment is completed as of 4/1/09.
Purpose:
To compare the efficacy of percutaneous closure of patent foramen oavale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with presumed paradoxical embolism.
Interventions:
PFO Closure + chronic antiplatelet therapy
For the non-surgical closure of a patent foramen ovale (PFO) in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale.
Chronic antiplatelet therapy (ASA or clopidogrel or association of ASA & dipyridamole).
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Location(s):
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, Germany, Poland, Portugal, Slovakia, Switzerland, and the United Kingdom
Year Started:
2000
Design:
Randomized, multi-center, multi-national clinical trial.
Inclusion Criteria
Patients under 60 years old, presence of PFO, ischemic stroke, clinically and radiologically verified extracranial peripheral thromboembolism.
Exclusion Criteria
Patients with any identifiable cause for the thromboembolic event other than PFO, previous surgical or percutaneous PFO closure, patients on chronic anticoagulant therapy for another disease.
Patient Involvement:
Patients will be stratified according to age (> 45 vs. < 45 years) and presence or absence of a septal aneurysm. Scheduled office visits at 6 months, 1, 2, 3, 4, and 5 years.
Primary Outcome:
Death, nonfatal stroke, and peripheral embolism.
Secondary Outcome:
New arrhythmia, myocardial infarction, rehospitalization related to PFO or its treatment, device problems (dislodgment, structural failure, infection, etc.), bleeding complications due to antithrombotic therapy.
Source of Information:
PC-Trial study protocol. Presented at 13th European Stroke Conference (May 2004). Presented at the 30th International Stroke Conference (February 2005).
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 09/28/2009.
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