Evaluation of Atorvastatin Treatment on Carotid Plaque.

Phase 3TerminatedNCT00343655

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Cardiovascular Diseases

Interventions

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Pfizer Investigational Site

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.

Comparison of effect of atorvastatin 80mg versus 10mg

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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