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

Coronary Arteriosclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380939
• Other study ID #: 0981-400-314
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2006
• Last updated: November 29, 2006
• Start date: April 1999
• Est. completion date: December 2000

Study information

• Verified date: November 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin

• Pravastatin

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Allentown	Pennsylvania
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Auburn	Maine
United States	Pfizer Investigational Site	Blue Island	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Elryia	Ohio
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Greensboro	North Carolina
United States	Pfizer Investigational Site	Greenville	North Carolina
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	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	Louisville	Kentucky
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	Royal Oak	Michigan
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Shawnee Mission	Kansas
United States	Pfizer Investigational Site	St Clair	Michigan
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change.
Secondary	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.
Secondary	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.

External Links

•   To obtain contact information for a study center near you, click here.