Evaluation of Atorvastatin Treatment on Carotid Plaque.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Hypercholesterolemia
Intervention: Atorvastatin (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Boston, Massachusetts 02114, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: September 2006
Ending date: June 2007
Last updated: February 19, 2008
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