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

Josep Rodes-Cabau

Status: Enrolling

Conditions: Ischemic Stroke; Bleeding Ulcer; Patent Foramen Ovale

Treatments: Other: Antiplatelet treatment discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT04475510

HALTI

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Successful transcatheter PFO closure with any approved device
• Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Antiplatelet treatment discontinuation

Experimental group

Description:

At 12 months post-PFO closure, patients will discontinue the antiplatelet treatment. All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.

Treatment:

Other: Antiplatelet treatment discontinuation