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. )

First Received on June 20, 2006. Last Updated on June 13, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00343655

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases	Drug: Atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	160
Study Start Date:	January 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343655

Locations

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00343655 History of Changes
Other Study ID Numbers:	A2581152
Study First Received:	June 20, 2006
Last Updated:	June 13, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Hypercholesterolemia

Additional relevant MeSH terms:

Cardiovascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012