Coronary Arteriosclerosis Clinical Trial
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
| Verified date | November 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries
| Status | Completed |
| Enrollment | 450 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Auchenflower | |
| Australia | Research Site | Clayton | |
| Australia | Research Site | Heidelberg | |
| Australia | Research Site | New Lambton | |
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Liege | |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ste-Foy | Quebec |
| France | Research Site | Creteil | |
| 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 | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milan | |
| Italy | Research Site | Mirano | Venezia |
| Italy | Research Site | Pavia | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Rome | |
| Italy | Research Site | Rozzano | Milan |
| Italy | Research Site | Siena | |
| Italy | Research Site | Udine | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Maastricht | |
| Netherlands | Research Site | Nieuwegein | |
| Netherlands | Research Site | Zwolle | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | |
| Spain | Research Site | Murias | |
| Spain | Research Site | Valladolid | |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Atlantis | Florida |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Danville | Pennsylvania |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Hartford | Connecticut |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Maywood | Illinois |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Petoskey | Michigan |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | St. Paul | Minnesota |
| United States | Research Site | Stockton | California |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Valhalla | New York |
| United States | Research Site | Williamsville | New York |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Australia, Belgium, Canada, France, Italy, Netherlands, Spain,
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 r — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | to evaluate whether treatment with rosuvastatin results in: | |||
| Secondary | Regression of coronary artery atheroma burden, as assessed by TAV | |||
| Secondary | Regression of coronary artery disease as measured by quantitative coronary angiography (QCA). | |||
| Secondary | To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. | |||
| Secondary | To evaluate the safety of rosuvastatin |
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