NCT00211705

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 1994

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1994

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

December 4, 2006

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

November 30, 2006

Conditions

Hyperlipidemia

Keywords

Hyperlipidemiacoronary heart diseasepreventionstrokepravastatin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

DietBEHAVIORAL
Diet+pravastatinDRUG

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 15329509BACKGROUND

  • 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.

    PMID: 17011942RESULT

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

    PMID: 38018702DERIVED

  • 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.

    PMID: 25135178DERIVED

  • 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.

    PMID: 24843520DERIVED

  • 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.

    PMID: 22573644DERIVED

  • 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.

    PMID: 21815708DERIVED

  • 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.

    PMID: 21593784DERIVED

  • 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.

    PMID: 19423108DERIVED

  • 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.

    PMID: 19104004DERIVED

  • 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.

    PMID: 18172039DERIVED

MeSH Terms

Conditions

HyperlipidemiasCoronary DiseaseStroke

Interventions

Diet

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Haruo Nakamura, MD

    Mitsukoshi Health and Welfare

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 1994

Study Completion

March 1, 2004

Last Updated

December 4, 2006

Record last verified: 2005-06