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Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
IUCPQ
Québec, Quebec, Canada
Start Date
July 8, 2020
Primary Completion Date
June 1, 2025
Completion Date
August 1, 2032
Last Updated
July 11, 2024
100
ESTIMATED participants
Antiplatelet treatment discontinuation
OTHER
Lead Sponsor
Josep Rodes-Cabau
NCT07371455
NCT07253181
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06990867