Cardiovascular Diseases
Conditions
Keywords
Hypercholesterolemia
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.
Interventions
DRUGAtorvastatin
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg. | — |
| Comparison of effect of atorvastatin 80mg versus 10mg | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology. | — |
| Correlation of biomarkers to carotid changes. | — |
| Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US. | — |
Countries
United States
Outcome results
None listed