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

November 29, 2006 updated by: Pfizer

A Prospective, Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Atorvastatin Versus Pravastatin on the Progression and Quantification of Coronary Atherosclerotic Lesions as Measured by Intravascular Ultrasound (REVERSAL)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103-8411
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Pfizer Investigational Site
    • Florida
      • Blue Island, Florida, United States, 60406
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49001
        • Pfizer Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Pfizer Investigational Site
      • St Clair, Michigan, United States, 48080
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • New York, New York, United States, 10029
        • Pfizer Investigational Site
      • Williamsville, New York, United States, 14221
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7594
        • Pfizer Investigational Site
      • Greensboro, North Carolina, United States, 27403
        • Pfizer Investigational Site
      • Greenville, North Carolina, United States, 27858-4354
        • Pfizer Investigational Site
      • Winston Salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195-5066
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Elryia, Ohio, United States, 44035
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43614
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18106
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
      • Providence, Rhode Island, United States, 02906
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78284-6205
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion

December 7, 2022

Study Completion

December 1, 2000

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0981-400-314

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Arteriosclerosis

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe