Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

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ClinicalTrials.gov Identifier: NCT00211705

Recruitment Status : Completed

First Posted : September 21, 2005

Last Update Posted : December 4, 2006

Sponsor:

Collaborators:

Daiichi Sankyo Co., Ltd.

Ministry of Health, Labour and Welfare, Japan

Information provided by:

Mitsukoshi Health and Welfare Foundation

Study Description

Brief Summary:

To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Behavioral: Diet Drug: Diet+pravastatin	Phase 4

Detailed Description:

MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice. Because the dose of pravastatin used in the MEGA Study was 10–20 mg/day, which is consistent with the approved doses in Japan and lower than the doses used in previous large-scale clinical trials.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	8000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Study Start Date :	February 1994
Study Completion Date :	March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know

Drug Information available for: Pravastatin

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]

Secondary Outcome Measures :

Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

TC:220～270mg/dl
Male: 40-70 years old/ female: postmenopausal-70 years old
<40kg in weight

Exclusion Criteria:

FH
History of CHD(angina, MI, post-PTCA/CABG, etc.)
History of CVA(stroke, TIA, etc.)
Underlying malignant tumor

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211705

Sponsors and Collaborators

Mitsukoshi Health and Welfare Foundation

Daiichi Sankyo Co., Ltd.

Ministry of Health, Labour and Welfare, Japan

Investigators

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Study Chair:	Haruo Nakamura, MD	Mitsukoshi Health and Welfare

More Information

Publications of Results:

Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi Y; MEGA Study Group. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Lancet. 2006 Sep 30;368(9542):1155-63.

Other Publications:

Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study Group. Design and baseline characteristics of a study of primary prevention of coronary events with pravastatin among Japanese with mildly elevated cholesterol levels. Circ J. 2004 Sep;68(9):860-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakamura H, Mizuno K; MEGA Study Group. Cardiovascular and cancer events in hyper-high-density lipoprotein cholesterolemic patients: a post hoc analysis of the MEGA study. Lipids Health Dis. 2014 Aug 18;13:133. doi: 10.1186/1476-511X-13-133.

Matsushima T, Nakaya N, Mizuno K, Ohashi Y, Teramoto T, Yokoyama S, Ichikawa S, Ishikura N, Kamiyama K, Nakamura H; MEGA Study Group. The effect of low-dose pravastatin in metabolic syndrome for primary prevention of cardiovascular disease in Japan: a post hoc analysis of the MEGA study. J Cardiovasc Pharmacol Ther. 2012 Jun;17(2):153-8. doi: 10.1177/1074248411421777. Epub 2011 Oct 3.

Tajima N, Kurata H, Ohashi Y, Mizuno K, Nakamura H. Management of Elevated Cholesterol in the primary prevention Group of Adult Japanese (MEGA) Study assists the view that a fasting plasma glucose level ≥100 mg/dL increases cardiovascular risk. J Diabetes Investig. 2011 Oct 7;2(5):399-405. doi: 10.1111/j.2040-1124.2011.00121.x.

Nakaya N, Mizuno K, Ohashi Y, Teramoto T, Yokoyama S, Hirahara K, Mizutani M, Nakamura H; MEGA Study Group. Low-dose pravastatin and age-related differences in risk factors for cardiovascular disease in hypercholesterolaemic Japanese: analysis of the management of elevated cholesterol in the primary prevention group of adult Japanese (MEGA study). Drugs Aging. 2011 Sep 1;28(9):681-92. doi: 10.2165/11595620-000000000-00000.

Kushiro T, Mizuno K, Nakaya N, Ohashi Y, Teramoto T, Yokoyama S, Kakinoki S, Nakamura H; MEGA Study Group. Blood pressure control status and effects of pravastatin on cardiovascular events occurrence in patients with dyslipidaemia. J Hum Hypertens. 2012 Jun;26(6):388-95. doi: 10.1038/jhh.2011.49. Epub 2011 May 19.

Nakamura H, Mizuno K, Ohashi Y, Yoshida T, Hirao K, Uchida Y; MEGA Study Group. Pravastatin and cardiovascular risk in moderate chronic kidney disease. Atherosclerosis. 2009 Oct;206(2):512-7. doi: 10.1016/j.atherosclerosis.2009.03.031. Epub 2009 Apr 5.

Kushiro T, Mizuno K, Nakaya N, Ohashi Y, Tajima N, Teramoto T, Uchiyama S, Nakamura H; Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group. Pravastatin for cardiovascular event primary prevention in patients with mild-to-moderate hypertension in the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study. Hypertension. 2009 Feb;53(2):135-41. doi: 10.1161/HYPERTENSIONAHA.108.120584. Epub 2008 Dec 22.

Mizuno K, Nakaya N, Ohashi Y, Tajima N, Kushiro T, Teramoto T, Uchiyama S, Nakamura H; MEGA Study Group. Usefulness of pravastatin in primary prevention of cardiovascular events in women: analysis of the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA study). Circulation. 2008 Jan 29;117(4):494-502. doi: 10.1161/CIRCULATIONAHA.106.671826. Epub 2008 Jan 2.

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ClinicalTrials.gov Identifier:	NCT00211705
Other Study ID Numbers:	MEGA
First Posted:	September 21, 2005 Key Record Dates
Last Update Posted:	December 4, 2006
Last Verified:	June 2005

Keywords provided by Mitsukoshi Health and Welfare Foundation:


Hyperlipidemia coronary heart disease prevention stroke pravastatin

Additional relevant MeSH terms:

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Hyperlipidemias Hyperlipoproteinemias Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Pravastatin	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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