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Several basic experimental studies have demonstrated that statins have beneficial effects for intracranial aneurysm (IA). Clinical studies on unruptured IAs, however, remain limited to four retrospective studies that have reached different conclusions. This study was the first open-label, multicenter, randomized controlled trial to assess the preventive effects of atorvastatin. Patients with unruptured small saccular IAs were randomly assigned to statin and control groups. The primary endpoint was a composite of aneurysm growth of ≥0.5 mm, new bleb formation confirmed from magnetic resonance (MR) angiography, and rupture. Enrollment was prematurely terminated due to unexpectedly slow enrollment. Of 231 patients (275 target IAs), 110 patients (128 IAs) were randomly assigned to the statin group and 121 patients (147 IAs) to the control group. After excluding 22 dropout patients, 107 IAs in the 93 statin group patients and 140 IAs in the 116 control group patients were finally analyzed. No significant differences of basic characteristics were evident between groups, except for significantly higher systolic pressure in the statin group (P = 0.03). The primary endpoint occurred in 28 IAs (20.0%) in the control group and in 17 IAs (15.9%) in the statin group. No aneurysm rupture was confirmed in either group. Significant beneficial effects of statin for IAs were not demonstrated for the primary endpoint (log-rank P = 0.359). This randomized trial did not establish any preventive effects of atorvastatin for unruptured small IAs. Further studies of larger cohorts are required to clarify the efficacy of statins for patients with unruptured IAs. Clinical trial registration: UMIN5135.

Small Unruptured Aneurysm Verification-prevention Effect against Growth of Cerebral Aneurysm Study Using Statin