Randomised multicentre clinical trial on early recurrence of stroke caused by mobile carotid plaques according to acute phase treatment: The PLACA VIL Trial

Abstract

Background: Stroke has a great impact on society, being the leading cause of adult disability and the second cause of death worldwide. Among the different etiopathogenetic mechanisms of ischemic stroke, atherothrombotic stroke accounts for 17-20%, the majority due to significant stenosis of the internal carotid artery. However, there is a relevant proportion of patients with atherothrombotic strokes associated with mobile carotid plaques (MCP), without significant carotid artery stenosis. These plaques seem to be associated with a high risk of recurrence but its prevalence and treatment is, nowadays, unknown and controversial. Objective: The main objective of this study is to assess if patients with atherothrombotic ischemic stroke associated to MCP treated surgically in the acute phase (by Carotid Endarterectomy [CEA] or by Carotid Angioplasty with Stenting) have a lower risk of early recurrence than those treated with Best Medical Treatment (BMT). The secondary objectives aim to determine, if stroke recurrence at one month, three months and one year post-index stroke is associated with adjudicated treatment in acute phase (CEA/stent vs. BMT) and/or presence of cerebral microembolic signals (MEs). Finally, we will analyse outcome at month 3, using the modified Rankin Scale (mRS), in each group of treatment