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

Phase 3

Completed

• Conditions: Coronary Arteriosclerosis

• Registration Number: NCT00240318
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-10-16
• Study First Submitted QC: 2005-10-16
• Study First Posted: 2005-10-18
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Regression of coronary artery atheroma burden, as assessed by TAV
to evaluate whether treatment with rosuvastatin results in:
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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Valladolid, Spain