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

Last updated: March 23, 2026
Sponsor: Josep Rodes-Cabau
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Thrombosis

Cardiac Ischemia

Treatment

Antiplatelet treatment discontinuation

Clinical Study ID

NCT04475510
HALTI
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successful transcatheter PFO closure with any approved device

  • Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergonesuccessful transcatheter PFO closure

Exclusion

Exclusion Criteria:

->60 year-old

  • RoPE score <6

  • Residual shunt ≥moderate following PFO closure

  • Atrial fibrillation following PFO closure

  • Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)

  • Diabetes mellitus

  • Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies,lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency,protein S deficiency)

  • Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure

  • Failure to provide signed informed consent

  • Absolute contraindications for an MRI study

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Antiplatelet treatment discontinuation
Phase:
Study Start date:
July 08, 2020
Estimated Completion Date:
August 01, 2032

Study 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.

Connect with a study center

  • IUCPQ

    Québec, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • IUCPQ

    Quebec, G1V 4G5
    Canada

    Site Not Available

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