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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diet
Diet+pravastatin
Sponsored by
Mitsukoshi Health and Welfare Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia focused on measuring Hyperlipidemia, coronary heart disease, prevention, stroke, pravastatin

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    November 30, 2006
    Sponsor
    Mitsukoshi Health and Welfare Foundation
    Collaborators
    Daiichi Sankyo Co., Ltd., Ministry of Health, Labour and Welfare, Japan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00211705
    Brief Title
    Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
    Official Title
    Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitsukoshi Health and Welfare Foundation
    Collaborators
    Daiichi Sankyo Co., Ltd., Ministry of Health, Labour and Welfare, Japan

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia
    Keywords
    Hyperlipidemia, coronary heart disease, prevention, stroke, pravastatin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet
    Intervention Type
    Drug
    Intervention Name(s)
    Diet+pravastatin
    Primary Outcome Measure Information:
    Title
    Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
    Secondary Outcome Measure Information:
    Title
    Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haruo Nakamura, MD
    Organizational Affiliation
    Mitsukoshi Health and Welfare
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15329509
    Citation
    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. doi: 10.1253/circj.68.860.
    Results Reference
    background
    PubMed Identifier
    17011942
    Citation
    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. doi: 10.1016/S0140-6736(06)69472-5.
    Results Reference
    result
    PubMed Identifier
    25135178
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    22573644
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    24843520
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    21815708
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    21593784
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19423108
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19104004
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    18172039
    Citation
    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.
    Results Reference
    derived

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

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