Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)|
- Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
- Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality
|Study Start Date:||February 1994|
|Estimated Study Completion Date:||March 2004|
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.