Evaluation of Atorvastatin Treatment on Carotid Plaque.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343655
Recruitment Status : 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 Posted : June 23, 2006
Last Update Posted : June 17, 2008
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
  2. Comparison of effect of atorvastatin 80mg versus 10mg

Secondary Outcome Measures :
  1. Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
  2. Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
  3. Correlation of biomarkers to carotid changes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343655

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00343655     History of Changes
Other Study ID Numbers: A2581152
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors