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A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin calcium
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical indication for coronary catheterization. Target Coronary Artery: The target vessel must have .50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment) and the vessel must be large enough to accommodate the IVUS catheter. A lesion of up to 60% is permitted distal to the target segment. Side branches of the target (imaged) vessel may be narrowed up to 70% by visual estimation, provided the target segment contains no lesion greater than 50%. Exclusion Criteria: Use of lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2. Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study. -

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Outcomes

Primary Outcome Measures

to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS

Secondary Outcome Measures

to evaluate whether treatment with rosuvastatin results in:
Regression of coronary artery atheroma burden, as assessed by TAV
Regression of coronary artery disease as measured by quantitative coronary angiography (QCA).
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
To evaluate the safety of rosuvastatin

Full Information

First Posted
October 16, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00240318
Brief Title
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
Official Title
A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin calcium
Other Intervention Name(s)
Crestor
Primary Outcome Measure Information:
Title
to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
Secondary Outcome Measure Information:
Title
to evaluate whether treatment with rosuvastatin results in:
Title
Regression of coronary artery atheroma burden, as assessed by TAV
Title
Regression of coronary artery disease as measured by quantitative coronary angiography (QCA).
Title
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
Title
To evaluate the safety of rosuvastatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical indication for coronary catheterization. Target Coronary Artery: The target vessel must have .50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment) and the vessel must be large enough to accommodate the IVUS catheter. A lesion of up to 60% is permitted distal to the target segment. Side branches of the target (imaged) vessel may be narrowed up to 70% by visual estimation, provided the target segment contains no lesion greater than 50%. Exclusion Criteria: Use of lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2. Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Crestor Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
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City
Santa Rosa
State/Province
California
Country
United States
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City
Stockton
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
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City
Hartford
State/Province
Connecticut
Country
United States
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City
Atlantis
State/Province
Florida
Country
United States
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City
Chicago
State/Province
Illinois
Country
United States
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City
Maywood
State/Province
Illinois
Country
United States
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City
Auburn
State/Province
Maine
Country
United States
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City
Baltimore
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Maryland
Country
United States
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City
Ann Arbor
State/Province
Michigan
Country
United States
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Petoskey
State/Province
Michigan
Country
United States
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Minneapolis
State/Province
Minnesota
Country
United States
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St. Paul
State/Province
Minnesota
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United States
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Buffalo
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New York
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United States
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City
Valhalla
State/Province
New York
Country
United States
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Williamsville
State/Province
New York
Country
United States
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City
Chapel Hill
State/Province
North Carolina
Country
United States
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Toledo
State/Province
Ohio
Country
United States
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Danville
State/Province
Pennsylvania
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United States
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Houston
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Texas
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United States
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Milwaukee
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Wisconsin
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United States
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Auchenflower
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Australia
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Clayton
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Australia
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Heidelberg
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Australia
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City
New Lambton
Country
Australia
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Aalst
Country
Belgium
Facility Name
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City
Bruxelles
Country
Belgium
Facility Name
Research Site
City
Edegem
Country
Belgium
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City
Liege
Country
Belgium
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Halifax
State/Province
Nova Scotia
Country
Canada
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Montreal
State/Province
Quebec
Country
Canada
Facility Name
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City
Ste-Foy
State/Province
Quebec
Country
Canada
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Creteil
Country
France
Facility Name
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City
Limoges
Country
France
Facility Name
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Lyon
Country
France
Facility Name
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City
Massy
Country
France
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Melun
Country
France
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Paris
Country
France
Facility Name
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Pessac
Country
France
Facility Name
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Toulouse
Country
France
Facility Name
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City
Rozzano
State/Province
Milan
Country
Italy
Facility Name
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City
Mirano
State/Province
Venezia
Country
Italy
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Genova
Country
Italy
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Milan
Country
Italy
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Pavia
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Italy
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Pisa
Country
Italy
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Rome
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Italy
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Siena
Country
Italy
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Udine
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Italy
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Amsterdam
Country
Netherlands
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Maastricht
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Netherlands
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Nieuwegein
Country
Netherlands
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Zwolle
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Netherlands
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Barcelona
Country
Spain
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Madrid
Country
Spain
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Malaga
Country
Spain
Facility Name
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Murias
Country
Spain
Facility Name
Research Site
City
Valladolid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16533939
Citation
Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. doi: 10.1001/jama.295.13.jpc60002. Epub 2006 Mar 13.
Results Reference
result

Learn more about this trial

A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)

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