Clinical trial NCT00640744: Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions
Official title: Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Keywords: Atherogenesis
Atheroma
Arteriosclerosis
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-03-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in carotid plaque composition as assessed by MRI and histology
timeFrame: 3 months
Secondary outcomes:
measure: Changes content of cells, proteins and genes in carotid plaque
timeFrame: 3 months
measure: Changes in content of selected proteins and their encoding genes in carotid plaques
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Joel D Morrisett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Addison M Taylor, MD, PhD
role: STUDY_DIRECTOR
affiliation: Baylor College of Medicine
name: William Insull, MD
role: STUDY_CHAIR
References:
citation: Choudhary S, Higgins CL, Chen IY, Reardon M, Lawrie G, Vick GW 3rd, Karmonik C, Via DP, Morrisett JD. Quantitation and localization of matrix metalloproteinases and their inhibitors in human carotid endarterectomy tissues. Arterioscler Thromb Vasc Biol. 2006 Oct;26(10):2351-8. doi: 10.1161/01.ATV.0000239461.87113.0b. Epub 2006 Aug 3.