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

Phase 4

• Conditions: Atherosclerosis
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00640744
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Atorvastatin	An untreated carotid plaque will be obtained at the first endarterectomy. Atorvastatin 80mg will be administered for 3 months. The contralateral (treated) plaque will be obtained at the second endarterectomy. Hence, each patient will be his/her own control

Primary Outcome Measures

Name	Time	Method
Changes in carotid plaque composition as assessed by MRI and histology	3 months

Secondary Outcome Measures

Name	Time	Method
Changes content of cells, proteins and genes in carotid plaque	3 months
Changes in content of selected proteins and their encoding genes in carotid plaques	3 months

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States