This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

Pfizer600 enrolled

Overview

This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Coronary Arteriosclerosis

Interventions

AtorvastatinDRUG

PravastatinDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl. Exclusion Criteria: * Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.

Locations (36)

Outcomes

Primary Outcomes

The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18.

The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change.

Secondary Outcomes

The nominal change (month 18 - baseline) in total plaque volume as measured by the sum of plaque areas for all slices of anatomically comparable segments of the target coronary artery.

Changes in brachial artery vasoactivity will be correlated with changes in total cholesterol, LDL-C, triglyceride and apolipoprotein B levels following 3 months of treatment.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Denver, Colorado, United States

Pfizer Investigational Site

BLUE Island, Florida, United States

Pfizer Investigational Site

Gainesville, Florida, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Shawnee Mission, Kansas, United States

...and 26 more locations