About this trial
In patients with internal carotid artery (ICA) stenosis of 50% or greater (measured according to the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)) who have experienced a transient ischemic attack (TIA) or minor ipsilateral stroke, carotid endarterectomy (CEA) offers maximum benefit if performed within 15 days of the initial ischemic symptom. National and international guidelines recommend surgical treatment (CEA) within this timeframe; however, no studies have specifically evaluated the optimal timing for CEA after a TIA or minor stroke.
It is well established that the risk of a major stroke is highest in the first few days following a transient ischemic attack or minor stroke and then decreases over the subsequent days and weeks.
This raises the hypothesis that performing an urgent carotid endarterectomy (within 3 days) may provide greater benefit compared to a delayed procedure (between 4 and 15 days).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
CEA (carotid endarterectomy)
Procedure/SurgeryIntervention (CEA) is associated to both arms (group A and B)
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0
Number of patients experiencing death, any type of stroke, and myocardial infarction within 90 days of the ischemic event in group A and B (numerical values)
Secondary outcomes
Number of participants with treatment-related ipsilateral ischemic stroke events as assessed by CTCAE v4.0
Number of patients experiencing ipsilateral ischemic stroke within 90 days of the ischemic event in group A and B. (numerical values)
Number of participants with treatment-related cerebral hemorrhagic events as assessed by CTCAE v4.0
To demonstrate that urgent CEA (within 72 hours) is as safe as delayed CEA (after 72 hours) in terms of number of cerebral hemorrhagic events.
Sponsors and contacts
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