Evaluation of Atorvastatin Treatment on Carotid Plaque.

This study has been terminated.

(The study was terminated on June 22, 2007 for inability to enroll patients within an appropriate timeframe. There were no efficacy/safety concerns.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00343655

First received: June 20, 2006

Last updated: June 13, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2006

Last Updated Date

June 13, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
Comparison of effect of atorvastatin 80mg versus 10mg

Original Primary Outcome Measures ^ICMJE

Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg. Comparison of effect of atorvastatin 80mg versus 10mg

Change History

Complete list of historical versions of study NCT00343655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
Correlation of biomarkers to carotid changes.

Original Secondary Outcome Measures ^ICMJE

Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US. Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology. Correlation of biomarkers to carotid changes.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Atorvastatin Treatment on Carotid Plaque.

Official Title ^ICMJE

A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool

Brief Summary

The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cardiovascular Diseases

Intervention ^ICMJE

Drug: Atorvastatin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

160

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.

Exclusion Criteria:

Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
Subjects currently on high dose statin, and
Subjects with contraindications for MRI or statin therapy.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00343655

Other Study ID Numbers ^ICMJE

A2581152

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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