Evaluation of Atorvastatin Treatment on Carotid Plaque.
Phase 3
Terminated
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT00343655
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Boston, Massachusetts, United States
Pfizer Investigational Site🇺🇸Boston, Massachusetts, United States