Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, coronary heart disease, prevention, stroke, pravastatin
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization] | — |
Secondary
| Measure | Time frame |
|---|---|
| Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality | — |