Rationale and design of assessment of lipophilic vs. hydrophilic statin therapy in acute myocardial infarction (the ALPS-AMI) study.

BACKGROUND: Statins reduce the incidence of cardiovascular events in patients with acute myocardial infarction (AMI). Although all statins are equally effective in secondary prevention, there might be certain differences in the effects of lipophilic and hydrophilic statins. Therefore, our aim is to compare the effectiveness of lipophilic atorvastatin and hydrophilic pravastatin in secondary prevention after AMI. METHODS AND RESULTS: This study is a prospective, randomized, open-label, multicenter study of 500 patients with AMI. Patients that have undergone successful percutaneous coronary intervention will be randomly allocated to receive either atorvastatin or pravastatin with the treatment goal of lowering their low-density lipoprotein-cholesterol level below 100 mg/dl for 2 years. The primary endpoint will be death due to any cause, nonfatal MI, nonfatal stroke, unstable angina, or congestive heart failure requiring hospital admission, or any type of coronary revascularization. CONCLUSION: This is the first multicenter trial to compare the effects and safety of lipophilic and hydrophilic statin therapy in Japanese patients with AMI. It addresses an important issue and could influence the use of statin treatment in the secondary prevention of coronary artery disease.