Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke — HALTI  

Ischemic Stroke Clinical Trial

Official title: Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Bleeding Ulcer
• Foramen Ovale, Patent
• Hemorrhage
• Ischemic Stroke
• Patent Foramen Ovale
• Stroke

• 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