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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin calcium | Drug |
|
| Measure | Description | 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 |
| Measure | Description | 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). |
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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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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Crestor Medical Sciences Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16533939 | Result | 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. |
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| To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. |
| To evaluate the safety of rosuvastatin |
| Los Angeles |
| California |
| United States |
| Research Site | San Francisco | California | United States |
| Research Site | Santa Rosa | California | United States |
| Research Site | Stockton | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Hartford | Connecticut | United States |
| Research Site | Atlantis | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Maywood | Illinois | United States |
| Research Site | Auburn | Maine | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | Petoskey | Michigan | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Valhalla | New York | United States |
| Research Site | Williamsville | New York | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Danville | Pennsylvania | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Auchenflower | Australia |
| Research Site | Clayton | Australia |
| Research Site | Heidelberg | Australia |
| Research Site | New Lambton | Australia |
| Research Site | Aalst | Belgium |
| Research Site | Brussels | Belgium |
| Research Site | Edegem | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Ste-Foy | Quebec | Canada |
| Research Site | Créteil | France |
| Research Site | Limoges | France |
| Research Site | Lyon | France |
| Research Site | Massy | France |
| Research Site | Melun | France |
| Research Site | Paris | France |
| Research Site | Pessac | France |
| Research Site | Toulouse | France |
| Research Site | Rozzano | Milan | Italy |
| Research Site | Mirano | Venezia | Italy |
| Research Site | Genova | Italy |
| Research Site | Milan | Italy |
| Research Site | Pavia | Italy |
| Research Site | Pisa | Italy |
| Research Site | Rome | Italy |
| Research Site | Siena | Italy |
| Research Site | Udine | Italy |
| Research Site | Amsterdam | Netherlands |
| Research Site | Maastricht | Netherlands |
| Research Site | Nieuwegein | Netherlands |
| Research Site | Zwolle | Netherlands |
| Research Site | Barcelona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Málaga | Spain |
| Research Site | Murias | Spain |
| Research Site | Valladolid | Spain |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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