Bleeding Ulcer, Ischemic Stroke, Patent Foramen Ovale
Conditions
Keywords
Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients
Brief summary
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
OTHERAntiplatelet 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.
Sponsors
Josep Rodes-Cabau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of new stroke events | 12 months | 1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR \< 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death. |
| Presence of new ischemic lesions | 24-month follow-up | Evaluated by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of new cerebral ischemic lesions | 24-month follow-up | Evaluated by MRI |
| Volume of new cerebral ischemic lesions | 24-month follow-up | Evaluated by MRI |
| Number of ischemic events | 24-month follow-up | Stroke, TIA |
| Rate of bleeding | 24-month follow-up | Life-threatening, major or minor bleeding |
Countries
Canada
Contacts
CONTACTJosep Rodes-Cabau, MD
CONTACTMelanie Cote, MSc
Outcome results
None listed