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

This study has been completed.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00240318
  Purpose

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


Condition Intervention Phase
Coronary Arteriosclerosis
Drug: Rosuvastatin calcium
Phase III

MedlinePlus related topics:   Coronary Artery Disease    Ultrasound   

Drug Information available for:   Rosuvastatin    Rosuvastatin calcium    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by AstraZeneca:

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

Estimated Enrollment:   450
Study Start Date:   November 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240318

Show 62 study locations  Show 62 Study Locations

Sponsors and Collaborators
AstraZeneca

Investigators
Study Director:     AstraZeneca Crestor Medical Sciences Director, MD     AstraZeneca    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   D3562C00076
First Received:   October 16, 2005
Last Updated:   May 2, 2006
ClinicalTrials.gov Identifier:   NCT00240318
Health Authority:   United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Coronary Artery Disease  

Study placed in the following topic categories:
Coronary Disease
Arterial Occlusive Diseases
Rosuvastatin
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2008




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