A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
Study Details
Study Description
Brief Summary
The purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA []
Secondary Outcome Measures
- Assess the effects of rosuvastatin treatment on the following variables, with the same analyses being applied to the IMT variables: []
- Change in the mean maximum IMT of the near & far walls of the right & left CCA, carotid bulb, ICA []
- Change in the mean IMT of the near & far walls of the right & left CCA []
- Change in LDL-C, TC, HDL-C, TG, nonHDL-C, ApoB, ApoA-I, nonHDL-C/HDL-C, & ApoB/ApoA-I []
- Change in inflammatory marker: C-reactive protein (CRP) []
- Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Maximum IMT >1.2 mm and 3.5 mm at any location in the carotid ultrasound studies conducted at both Visit 2 (Week -4) and Visit 3 (Week -2)
-
Subjects with age and no other risk factor: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1mmol/L) and <190 mg/dL (4.9 mmol/L)
-
Subjects with 2 or more risk factors and a 10-year coronary heart disease (CHD) risk < 10%: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1 mmol/L)
Exclusion Criteria:
-
Use of pharmacologic lipid-lowering medications (eg, HMG-CoA reductase inhibitors, fibrate derivatives, bile acid binding resins, niacin or its analogues at doses >400 mg) within 12 months prior to Visit 1 (Week -6).
-
Clinical evidence of coronary artery disease or any other atherosclerotic disease such as angina, MI, TIA, symptomatic carotid artery disease, CVA, CABG, PTCA, peripheral arterial disease, AAA.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Alhambra | California | United States | |
| 2 | Research Site | La Jolla | California | United States | |
| 3 | Research Site | Los Angeles | California | United States | |
| 4 | Research Site | San Diego | California | United States | |
| 5 | Research Site | Santa Ana | California | United States | |
| 6 | Research Site | Chicago | Illinois | United States | |
| 7 | Research Site | Boston | Massachusetts | United States | |
| 8 | Research Site | Brooklyn Center | Minnesota | United States | |
| 9 | Research Site | Minneapolis | Minnesota | United States | |
| 10 | Research Site | Salisbury | North Carolina | United States | |
| 11 | Research Site | Winston-Salem | North Carolina | United States | |
| 12 | Research Site | Cincinnati | Ohio | United States | |
| 13 | Research Site | Glen Mills | Pennsylvania | United States | |
| 14 | Research Site | Philadelphia | Pennsylvania | United States | |
| 15 | Research Site | Pittsburgh | Pennsylvania | United States | |
| 16 | Research Site | Houston | Texas | United States | |
| 17 | Research Site | Kirkland | Washington | United States | |
| 18 | Research Site | Renton | Washington | United States | |
| 19 | Research Site | Seattle | Washington | United States | |
| 20 | Research Site | Madison | Wisconsin | United States | |
| 21 | Research Site | Brussels (Anderlecht) | Belgium | ||
| 22 | Research Site | Brussels | Belgium | ||
| 23 | Research Site | Leuven | Belgium | ||
| 24 | Research Site | Praha 2 | Czech Republic | ||
| 25 | Research Site | Slaný | Czech Republic | ||
| 26 | Research Site | Kuopio | Finland | ||
| 27 | Research Site | Auboue | France | ||
| 28 | Research Site | Bagnolet | France | ||
| 29 | Research Site | Boulogne Billancourt | France | ||
| 30 | Research Site | Briey | France | ||
| 31 | Research Site | Delme | France | ||
| 32 | Research Site | Drancy | France | ||
| 33 | Research Site | Fresnes En Woevre | France | ||
| 34 | Research Site | Ivry Sur Seine | France | ||
| 35 | Research Site | Jarny | France | ||
| 36 | Research Site | Les Lilas | France | ||
| 37 | Research Site | Marange Silvange | France | ||
| 38 | Research Site | Mars La Tour | France | ||
| 39 | Research Site | Metz | France | ||
| 40 | Research Site | Meudon | France | ||
| 41 | Research Site | Montigny Les Metz | France | ||
| 42 | Research Site | Moutiers | France | ||
| 43 | Research Site | Paris cedex 14 | France | ||
| 44 | Research Site | Paris | France | ||
| 45 | Research Site | St Germain En Laye | France | ||
| 46 | Research Site | Thionville | France | ||
| 47 | Research Site | Yerres | France | ||
| 48 | Research Site | Yutz | France | ||
| 49 | Research Site | München | Bayern | Germany | |
| 50 | Research Site | Essen | Nordrhein-Westfalen | Germany | |
| 51 | Research Site | Essen | Germany | ||
| 52 | Research Site | München | Germany | ||
| 53 | Research Site | Amsterdam | Netherlands | ||
| 54 | Research Site | Rotterdam | Netherlands | ||
| 55 | Research Site | Utrecht | Netherlands | ||
| 56 | Research Site | Bekkestua | Norway | ||
| 57 | Research Site | Oslo | Norway | ||
| 58 | Research Site | Skedsmokorset | Norway |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: AstraZeneca Crestor Medical Science Director, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4522IL/0088
- METEOR
- D3562C00088