Clinical trial NCT00240318: A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Arteriosclerosis
Keywords: Coronary Artery Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

-

Primary outcomes:
measure: 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 outcomes:
measure: to evaluate whether treatment with rosuvastatin results in:
measure: Regression of coronary artery atheroma burden, as assessed by TAV
measure: Regression of coronary artery disease as measured by quantitative coronary angiography (QCA).
measure: To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
measure: To evaluate the safety of rosuvastatin
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Maywood
country: United States
facility: Research Site
state: Illinois
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Petoskey
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Valhalla
country: United States
facility: Research Site
state: New York
city: Williamsville
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Danville
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Auchenflower
country: Australia
facility: Research Site
city: Clayton
country: Australia
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: New Lambton
country: Australia
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Creteil
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Massy
country: France
facility: Research Site
city: Melun
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
state: Milan
city: Mirano
country: Italy
facility: Research Site
state: Venezia
city: Genova
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murias
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.