Coronary Arteriosclerosis
Conditions
Keywords
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
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Belgium, Canada, France, Italy, Netherlands, Spain, United States
Outcome results
None listed