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Recruiting NCT04475510

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

No phase Interventional Patent Foramen Ovale Ischemic Stroke Bleeding Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antiplatelet treatment discontinuation.
Who it may be relevant to
Registry conditions: Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed 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.

Interventions

  • Other Antiplatelet treatment discontinuation
    All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.

Primary outcome measures

  • Presence of new stroke events [Time frame: 12 months]
  • Presence of new ischemic lesions [Time frame: 24-month follow-up]
Secondary outcome measures (12)
  • Number of new cerebral ischemic lesions [Time frame: 24-month follow-up]
  • Volume of new cerebral ischemic lesions [Time frame: 24-month follow-up]
  • Number of ischemic events [Time frame: 24-month follow-up]
  • Number of ischemic events [Time frame: 3-year follow-up]
  • Number of ischemic events [Time frame: 4-year follow-up]
  • Number of ischemic events [Time frame: 5-year follow-up]
  • Number of ischemic events [Time frame: 6-year follow-up]
  • Number of ischemic events [Time frame: 7-year follow-up]
  • Number of ischemic events [Time frame: 8-year follow-up]
  • Number of ischemic events [Time frame: 9-year follow-up]
  • Number of ischemic events [Time frame: 10-year follow-up]
  • Rate of bleeding [Time frame: 24-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • IUCPQ — Québec

Identifiers

NCT: NCT04475510 · HALTI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗