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

Phase 4

Completed

• Conditions: Coronary Arteriosclerosis

• Registration Number: NCT00380939
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Study Completion: 2000-12
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-27
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-29
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Seattle, Washington, United States