This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.
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)
1 other identifier
interventional
600
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 1999
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedDecember 4, 2006
November 1, 2006
September 26, 2006
November 29, 2006
Conditions
Outcome Measures
Primary Outcomes (2)
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 (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (36)
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Los Angeles, California, 90095, United States
Pfizer Investigational Site
San Diego, California, 92103-8411, United States
Pfizer Investigational Site
Denver, Colorado, 80262, United States
Pfizer Investigational Site
BLUE Island, Florida, 60406, United States
Pfizer Investigational Site
Gainesville, Florida, 32610, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Chicago, Illinois, 60637, United States
Pfizer Investigational Site
Shawnee Mission, Kansas, 66204, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Auburn, Maine, 04210, United States
Pfizer Investigational Site
Boston, Massachusetts, 02111, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49001, United States
Pfizer Investigational Site
Royal Oak, Michigan, 48073, United States
Pfizer Investigational Site
Saint Clair, Michigan, 48080, United States
Pfizer Investigational Site
Rochester, Minnesota, 55905, United States
Pfizer Investigational Site
Albany, New York, 12208, United States
Pfizer Investigational Site
New York, New York, 10029, United States
Pfizer Investigational Site
Williamsville, New York, 14221, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7594, United States
Pfizer Investigational Site
Greensboro, North Carolina, 27403, United States
Pfizer Investigational Site
Greenville, North Carolina, 27858-4354, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195-5066, United States
Pfizer Investigational Site
Columbus, Ohio, 43210, United States
Pfizer Investigational Site
Elryia, Ohio, 44035, United States
Pfizer Investigational Site
Toledo, Ohio, 43614, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18106, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Pfizer Investigational Site
Providence, Rhode Island, 02903, United States
Pfizer Investigational Site
Providence, Rhode Island, 02906, United States
Pfizer Investigational Site
San Antonio, Texas, 78284-6205, United States
Pfizer Investigational Site
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 27, 2006
Study Start
April 1, 1999
Study Completion
December 1, 2000
Last Updated
December 4, 2006
Record last verified: 2006-11