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NCT00343655 Clinical Trial

Evaluation of Atorvastatin Treatment on Carotid Plaque.

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00343655
Other study ID # A2581152
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2007
Est. completion date August 2007

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 160
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
United States Pfizer Investigational Site Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
Primary Comparison of effect of atorvastatin 80mg versus 10mg
Secondary Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
Secondary Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
Secondary Correlation of biomarkers to carotid changes.
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