Angiographic intervention trial using HMG CoA reductase inhibitor to evaluate retardation of obstructive multiple atheroma in West Japan (ATHEROMA study): rationale, design and baseline.

The ATHEROMA study is a prospective, multicentre, randomized controlled study in Japan to assess the changes of coronary atherosclerosis of patients with pre-existing coronary artery disease (CAD) by cholesterol-lowering therapy (CLT) using pravastatin 10-20 mg per day for 3 years. The primary objective is to evaluate the changes in coronary minimum lumen diameters by quantitative coronary arteriography, and the secondary outcome is to observe morphological changes of plaques and clinical events including mortality, recurrence of CAD and the requirement of any coronary intervention. The primary objective will test the hypothesis that CLT results in a beneficial effect on coronary vessels in patients with coronary atherosclerosis in Japan, where the incidence of CAD is the lowest among industrialized countries.