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

NCT ID: NCT00240318

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Arteriosclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosuvastatin calcium

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Crestor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Crestor Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Birmingham, Alabama, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Santa Rosa, California, United States

Site Status

Research Site

Stockton, California, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Hartford, Connecticut, United States

Site Status

Research Site

Atlantis, Florida, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Maywood, Illinois, United States

Site Status

Research Site

Auburn, Maine, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Ann Arbor, Michigan, United States

Site Status

Research Site

Petoskey, Michigan, United States

Site Status

Research Site

Minneapolis, Minnesota, United States

Site Status

Research Site

Saint Paul, Minnesota, United States

Site Status

Research Site

Buffalo, New York, United States

Site Status

Research Site

Valhalla, New York, United States

Site Status

Research Site

Williamsville, New York, United States

Site Status

Research Site

Chapel Hill, North Carolina, United States

Site Status

Research Site

Toledo, Ohio, United States

Site Status

Research Site

Danville, Pennsylvania, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Research Site

Auchenflower, , Australia

Site Status

Research Site

Clayton, , Australia

Site Status

Research Site

Heidelberg, , Australia

Site Status

Research Site

New Lambton, , Australia

Site Status

Research Site

Aalst, , Belgium

Site Status

Research Site

Brussels, , Belgium

Site Status

Research Site

Edegem, , Belgium

Site Status

Research Site

Liège, , Belgium

Site Status

Research Site

Halifax, Nova Scotia, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Ste-Foy, Quebec, Canada

Site Status

Research Site

Créteil, , France

Site Status

Research Site

Limoges, , France

Site Status

Research Site

Lyon, , France

Site Status

Research Site

Massy, , France

Site Status

Research Site

Melun, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Pessac, , France

Site Status

Research Site

Toulouse, , France

Site Status

Research Site

Rozzano, Milan, Italy

Site Status

Research Site

Mirano, Venezia, Italy

Site Status

Research Site

Genova, , Italy

Site Status

Research Site

Milan, , Italy

Site Status

Research Site

Pavia, , Italy

Site Status

Research Site

Pisa, , Italy

Site Status

Research Site

Rome, , Italy

Site Status

Research Site

Siena, , Italy

Site Status

Research Site

Udine, , Italy

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Maastricht, , Netherlands

Site Status

Research Site

Nieuwegein, , Netherlands

Site Status

Research Site

Zwolle, , Netherlands

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Málaga, , Spain

Site Status

Research Site

Murias, , Spain

Site Status

Research Site

Valladolid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Canada France Italy Netherlands Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16533939 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D3562C00076

Identifier Type: -

Identifier Source: org_study_id