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

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Pravastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 26, 2006
Last Updated
November 29, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00380939
Brief Title
This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Primary Outcome Measure Information:
Title
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.
Title
The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change.
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8411
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Pfizer Investigational Site
City
Blue Island
State/Province
Florida
ZIP/Postal Code
60406
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Pfizer Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Pfizer Investigational Site
City
St Clair
State/Province
Michigan
ZIP/Postal Code
48080
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pfizer Investigational Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7594
Country
United States
Facility Name
Pfizer Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5066
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pfizer Investigational Site
City
Elryia
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Pfizer Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18106
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pfizer Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Pfizer Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-6205
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0981-400-314&StudyName=This+study+uses+ultrasound+to+determine+whether+atorvastatin+or+pravastatin+effects+the+progression+of+coronary+plaque%2E
Description
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Learn more about this trial

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

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