Background: Atorvastatin, rosuvastatin and pitavastatin are available for intensive, aggressive low-density lipoprotein cholesterol (LDL-C)-lowering therapy in clinical practice. The objective of the Randomized Head-to-Head Comparison of Pitavastatin, Atorvastatin, and Rosuvastatin for Safety and Efficacy (Quantity and Quality of LDL) (PATROL) Trial was to compare the safety and efficacy of atorvastatin, rosuvastatin and pitavastatin head to head in patients with hypercholesterolemia. This is the first prospective randomized multi-center trial to compare these strong statins (UMIN Registration No: 000000586). Methods and Results: Patients with risk factors for coronary artery disease and elevated LDL-C levels were randomized to receive atorvastatin (10mg/day), rosuvastatin (2.5mg/day), or pitavastatin (2mg/day) for 16 weeks. Safety was assessed in terms of adverse event rates, including abnormal clinical laboratory variables related to liver and kidney function and skeletal muscle. Efficacy was assessed by the changes in the levels and patterns of lipoproteins. Three hundred and two patients (from 51 centers) were enrolled, and these 3 strong statins equally reduced LDL-C and LDL particles, as well as fast-migrating LDL (modified LDL) by 40-45%. Newly developed pitavastatin was non-inferior to the other 2 statins in lowering LDL-C. There were no differences in the rate of adverse drug reactions among the 3 groups, but HbA_1c was increased while uric acid was decreased in the atorvastatin and rosuvastatin groups. Conclusions: The safety and efficacy of these 3 strong statins are equal. It is suggested that the use of these 3 statins be completely dependent on physician discretion based on patient background. (Circ J 2011; 75: 1493-1505)