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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.
Study NCT00240318   Information provided by AstraZeneca
First Received: October 16, 2005   Last Updated: March 25, 2009   History of Changes

October 16, 2005
March 25, 2009
November 2002
 
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
Same as current
Complete list of historical versions of study NCT00240318 on ClinicalTrials.gov Archive Site
  • 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
  • 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
 
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
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

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

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Coronary Arteriosclerosis
Drug: Rosuvastatin calcium
 
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.
 
Completed
450
November 2005
 

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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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
 
NCT00240318
 
D3562C00076
AstraZeneca
 
Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
AstraZeneca
March 2009

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