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A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)

NCT ID: NCT00225589

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesteremia

Keywords

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Hypercholesteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Rosuvastatin calcium

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Crestor Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Alhambra, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Brooklyn Center, Minnesota, United States

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Minneapolis, Minnesota, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Glen Mills, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Kirkland, Washington, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Brussels, , Belgium

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Brussels (Anderlecht), , Belgium

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Leuven, , Belgium

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Prague, , Czechia

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Slaný, , Czechia

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Kuopio, , Finland

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Auboué, , France

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Bagnolet, , France

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Boulogne-Billancourt, , France

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Briey, , France

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Delme, , France

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Drancy, , France

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Fresnes-en-Woëvre, , France

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Ivry-sur-Seine, , France

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Jarny, , France

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Les Lilas, , France

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Marange-Silvange, , France

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Mars-la-Tour, , France

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Metz, , France

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Meudon, , France

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Montigny-lès-Metz, , France

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Moûtiers, , France

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Paris, , France

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Saint-Germain-en-Laye, , France

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Thionville, , France

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Yerres, , France

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Yutz, , France

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München, Bavaria, Germany

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Essen, North Rhine-Westphalia, Germany

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Essen, , Germany

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München, , Germany

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Amsterdam, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Bekkestua, , Norway

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Oslo, , Norway

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Skedsmokorset, , Norway

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Countries

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United States Belgium Czechia Finland France Germany Netherlands Norway

References

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Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

Reference Type DERIVED
PMID: 37565307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23868083 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22884641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22536884 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22304793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21726301 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21617330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21546878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20412373 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19298496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17384434 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17355745 (View on PubMed)

Other Identifiers

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METEOR

Identifier Type: -

Identifier Source: secondary_id

D3562C00088

Identifier Type: OTHER

Identifier Source: secondary_id

4522IL/0088

Identifier Type: -

Identifier Source: org_study_id