Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions

• Status: Unknown status
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Men or women

• >18 yrs old

• Expected to have an endarterectomy on each carotid artery

• No contraindications for atorvastatin

• Stable cardiovascular health

• Lipid lowering treatment less than 6 mo duration

• Diabetic included if diabetes is controlled

• Patient is not claustrophobic

• Patient has evaluable carotid plaques.

Exclusion Criteria:

• Patient has had previous carotid endarterectomy,stenting, or other procedure

• Unstable cardiovascular status

• Hypersensitivity to statin therapy

• Neck anatomy preventing acquiring bilateral evaluable plaques

• Weight over 285 lbs.