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Background and purpose: The preventive effect of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in non-stroke Western patients. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study aims to determine the effect of pravastatin on carotid IMT in Japanese patients with hyperlipidemia with noncardioembolic ischemic stroke.Methods: This is a substudy of the J-STARS, a multicenter, randomized, open-label, blinded-endpoint, parallel-group trial to examine whether pravastatin reduces stroke recurrence in patients with noncardioembolic stroke. The patients were randomized to receive pravastatin (10 mg daily, usual dose in Japan) (pravastatin group) or not to receive any statins (control group). Carotid ultrasonography was performed by well-trained certified examiners and the recorded data was measured centrally. The primary outcome was IMT change of the distal wall in a continuous 2-cm section on the central side of the common carotid artery bifurcation over 5 years of observation. The IMT change was compared using mixed models for repeated measures.Results: Of 1578 patients who were enrolled in the J-STARS, 864 were registered in this echo substudy. After excluding 71 without baseline ultrasonography, 793 (530 men, 66.4±8.3 years old) were analyzed. Of the 793 patients, 388 were randomly assigned to the pravastatin group and 405 to the control group. Baseline characteristics were not significantly different except baseline NIH Stroke Scale [median 0 (IQR 0-2) vs. 1 (0-2), p=0.019] between the two groups. The baseline IMT (mean±SD) was 0.887±0.155 mm in the pravastatin group and 0.887±0.152 mm in the control group (p=0.990). Each annual change of the IMT (mean±SD) over 5 years of observation was 0.011±0.085 mm, 0.023±0.114 mm, 0.017±0.114 mm, 0.018±0.118 mm and 0.021±0.116 mm in the pravastatin group and 0.008±0.074 mm (p=0.650), 0.020±0.087 mm (p=0.985), 0.017±0.097 mm (p=0.586), 0.030±0.113 mm (p=0.202) and 0.040±0.118 mm (p=0.018) in the control group.Conclusion: Japanese usual dose of pravastatin significantly reduced the progression of carotid mean IMT at 5 years in patients with noncardioembolic stroke.