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Clinical Trial Summary

To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.


Clinical Trial Description

Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events. Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04475510
Study type Interventional
Source Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Contact Josep Rodes-Cabau, MD
Phone 4186568711
Email josep.rodes@criucpq.ulaval.ca
Status Recruiting
Phase N/A
Start date July 8, 2020
Completion date August 1, 2032

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