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

Tracking Information

First Received Date ^ICMJE

October 16, 2005

Last Updated Date

March 25, 2009

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00240318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Coronary Arteriosclerosis

Intervention ^ICMJE

Drug: Rosuvastatin calcium

Study Arms / Comparison Groups

Publications *

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. Epub 2006 Mar 13.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, France, Italy, Netherlands, Spain

Administrative Information

NCT ID ^ICMJE

NCT00240318

Responsible Party

Study ID Numbers ^ICMJE

D3562C00076

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Crestor Medical Sciences Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP