Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis — AMTEC  

Stroke Clinical Trial

Official title: Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis

Status Terminated

Clinical Trial Summary

The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

Clinical Trial Description

It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%.

Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients.

Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Stroke

• NCT number: NCT00805311
• Study type: Interventional
• Source: Russian Cardiology Research and Production Center
• Status: Terminated
• Phase: Phase 4
• Start date: April 2009
• Completion date: May 2014