Clinical trial NCT00225589: A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesteremia
Keywords: Hypercholesteremia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 840
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Assess the effects of rosuvastatin treatment on the following variables, with the same analyses being applied to the IMT variables:
measure: Change in the mean maximum IMT of the near & far walls of the right & left CCA, carotid bulb, ICA
measure: Change in the mean IMT of the near & far walls of the right & left CCA
measure: Change in LDL-C, TC, HDL-C, TG, nonHDL-C, ApoB, ApoA-I, nonHDL-C/HDL-C, & ApoB/ApoA-I
measure: Change in inflammatory marker: C-reactive protein (CRP)
measure: Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Brooklyn Center
country: United States
facility: Research Site
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Glen Mills
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Renton
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Brussels (Anderlecht)
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Slaný
country: Czech Republic
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Auboue
country: France
facility: Research Site
city: Bagnolet
country: France
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Briey
country: France
facility: Research Site
city: Delme
country: France
facility: Research Site
city: Drancy
country: France
facility: Research Site
city: Fresnes En Woevre
country: France
facility: Research Site
city: Ivry Sur Seine
country: France
facility: Research Site
city: Jarny
country: France
facility: Research Site
city: Les Lilas
country: France
facility: Research Site
city: Marange Silvange
country: France
facility: Research Site
city: Mars La Tour
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Meudon
country: France
facility: Research Site
city: Montigny Les Metz
country: France
facility: Research Site
city: Moutiers
country: France
facility: Research Site
city: Paris cedex 14
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: St Germain En Laye
country: France
facility: Research Site
city: Thionville
country: France
facility: Research Site
city: Yerres
country: France
facility: Research Site
city: Yutz
country: France
facility: Research Site
city: München
country: Germany
facility: Research Site
state: Bayern
city: Essen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Bekkestua
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Peters SA, Bots ML, Lind L, Groenewegen KA, de Korte C, den Ruijter HM; METEOR study group. The impact of variability in ultrasound settings on the measured echolucency of the carotid intima-media. J Hypertens. 2013 Sep;31(9):1861-7. doi: 10.1097/HJH.0b013e3283623548.
citation: Lind L, Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of rosuvastatin on the echolucency of the common carotid intima-media in low-risk individuals: the METEOR trial. J Am Soc Echocardiogr. 2012 Oct;25(10):1120-1127.e1. doi: 10.1016/j.echo.2012.07.004. Epub 2012 Aug 9.
citation: Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time. Curr Med Res Opin. 2012 Jun;28(6):891-9. doi: 10.1185/03007995.2012.689255. Epub 2012 Jun 6.
citation: Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.
citation: Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Lind L, Bots ML; METEOR Study Group. Manual or semi-automated edge detection of the maximal far wall common carotid intima-media thickness: a direct comparison. J Intern Med. 2012 Mar;271(3):247-56. doi: 10.1111/j.1365-2796.2011.02422.x. Epub 2011 Aug 11.
citation: Peters SA, Dogan S, Meijer R, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML. The use of plaque score measurements to assess changes in atherosclerotic plaque burden induced by lipid-lowering therapy over time: the METEOR study. J Atheroscler Thromb. 2011;18(9):784-95. doi: 10.5551/jat.8169. Epub 2011 May 27.
citation: Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of number of ultrasound examinations on the assessment of carotid intima-media thickness changes over time: the example of the METEOR study. J Hypertens. 2011 Jun;29(6):1145-54. doi: 10.1097/HJH.0b013e328345d85e.
citation: Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Raichlen JS, Bots ML. C-reactive protein lowering with rosuvastatin in the METEOR study. J Intern Med. 2010 Aug;268(2):155-61. doi: 10.1111/j.1365-2796.2010.02230.x. Epub 2010 Mar 6.
citation: Bots ML, Palmer MK, Dogan S, Plantinga Y, Raichlen JS, Evans GW, O'Leary DH, Grobbee DE, Crouse JR 3rd; METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study. J Intern Med. 2009 Jun;265(6):698-707. doi: 10.1111/j.1365-2796.2009.02073.x. Epub 2009 Mar 2.
citation: Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25.
citation: Crouse JR 3rd, Grobbee DE, O'Leary DH, Bots ML, Evans GW, Palmer MK, Riley WA, Raichlen JS; METEOR Study Group. Carotid intima-media thickness in low-risk individuals with asymptomatic atherosclerosis: baseline data from the METEOR study. Curr Med Res Opin. 2007 Mar;23(3):641-8. doi: 10.1185/030079907X178711.