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

Mitsukoshi Health and Welfare Foundation8,000 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

8,000

Conditions

Hyperlipidemia

Interventions

DietBEHAVIORAL

Diet+pravastatinDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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