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

NCT ID: NCT00640744

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Atherosclerosis

Keywords

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Atherogenesis Atheroma Arteriosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type OTHER

Atorvastatin

Intervention Type DRUG

Atorvastatin 80 mg tablet/day for 3 months

Interventions

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Atorvastatin

Atorvastatin 80 mg tablet/day for 3 months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Baylor College of Medicine

Principal Investigators

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Joel D Morrisett, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Addison M Taylor, MD, PhD

Role: STUDY_DIRECTOR

Baylor College of Medicine

William Insull, MD

Role: STUDY_CHAIR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William Insull, M.D.

Role: CONTACT

Phone: 713-798-4128

Email: [email protected]

Addison Taylor, MD/PhD

Role: CONTACT

Phone: 713-798-4721

Email: [email protected]

Facility Contacts

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Joel D Morrisett, PhD

Role: primary

Addison Taylor, MD/PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16888239 (View on PubMed)

Other Identifiers

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HL 063090

Identifier Type: -

Identifier Source: secondary_id

H-18077

Identifier Type: -

Identifier Source: org_study_id