| Descriptive Information Fields | |||||
|---|---|---|---|---|---|
| Brief Title † | 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 | ||||
| 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 |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome 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 Outcome Measure † | 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 |
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| Condition † | Coronary Arteriosclerosis | ||||
| Intervention † | Drug: Rosuvastatin calcium | ||||
| MEDLINE PMIDs | 16533939 | ||||
| Links | Related Info ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 450 | ||||
| Start Date † | November 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
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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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Australia, Belgium, Canada, France, Italy, Netherlands, Spain | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00240318 | ||||
| Organization ID | D3562C00076 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | AstraZeneca | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | April 2006 | ||||
| First Received Date † | October 16, 2005 | ||||
| Last Updated Date | May 2, 2006 | ||||