NCT00805311

Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Russian Cardiology Research and Production Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Carotid Artery Stenosis
• Atherosclerosis
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Carotid Endarterectomy	CEA involves a neck incision and physical removal of the plaque from the inside of the artery
DRUG	atorvastatin, aspirin, losartan, amlodipine	aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2008-12-09
• Last updated: 2015-10-12

Locations

2 sites across 1 country: Russia