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To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiplatelet treatment discontinuation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiplatelet treatment discontinuation | Other | All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of new stroke events | 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. | 12 months |
| Presence of new ischemic lesions | Evaluated by MRI | 24-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new cerebral ischemic lesions | Evaluated by MRI | 24-month follow-up |
| Volume of new cerebral ischemic lesions | Evaluated by MRI |
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Inclusion Criteria:
Exclusion Criteria:
->60 year-old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Rodes-Cabau, MD | Contact | 4186568711 | josep.rodes@criucpq.ulaval.ca | |
| Melanie Cote, MSc | Contact | 14186537270 | melanie.cote@criucpq.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUCPQ | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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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.
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| 24-month follow-up |
| Number of ischemic events | Stroke, TIA | 24-month follow-up |
| Number of ischemic events | Stroke, TIA | 3-year follow-up |
| Number of ischemic events | Stroke, TIA | 4-year follow-up |
| Number of ischemic events | Stroke, TIA | 5-year follow-up |
| Number of ischemic events | Stroke, TIA | 6-year follow-up |
| Number of ischemic events | Stroke, TIA | 7-year follow-up |
| Number of ischemic events | Stroke, TIA | 8-year follow-up |
| Number of ischemic events | Stroke, TIA | 9-year follow-up |
| Number of ischemic events | Stroke, TIA | 10-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 24-month follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 3-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 4-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 5-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 6-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 7-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 8-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 9-year follow-up |
| Rate of bleeding | Life-threatening, major or minor bleeding | 10-year follow-up |
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D000083242 | Ischemic Stroke |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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