The Atorvastatin During Ischemic Stroke study: a pilot randomized controlled trial

Objectives - Statins have antioxidant, antiinflammatory, anticoagulant and profibrinolythic properties that might play a useful role in the acute phase of ischemic stroke. This pilot study assessed the possible neuroprotective action of high-dose atorvastatin administration during the first week after an ischemic stroke, in order to obtain data for planning a wider multicenter study. Methods – Sixty-two patients with ischemic stroke, aged 75.3±11.9 (SD) years, 68% women, were randomized into a placebo (N=31) and an atorvastatin 80 mg/day (N=31) group. The double-blind treatment lasted 7 days. The primary end-point was a decrease of National Institutes of Health Stroke Scale (NIHSS) score >=4 points after 7 days. Infarct volume measured on CT scan after 3 days and a modified Rankin Scale (mRS)<2 at 3 months were secondary end-points. Results – There was no difference in the primary end-point between the 2 groups (odds ratio atorvastatin vs. placebo 0.74, 95% CI 0.26-2.17). Infarct volume was also similar in the 2 groups. Instead, there were more patients with mRS<2 at 3 months in the atorvastatin than in the placebo group (adjusted odds ratio 6.7; 95% CI 1.0-45.0; P=0.05). This prevalence concerned only the subgroup with mild strokes (NIHSS<=10; respectively 53.8% vs. 15.4%; P=0.04). Atorvastatin was well tolerated. Conclusions – This pilot study was unable to show any short-term benefit of atorvastatin during the acute phase of ischemic stroke. However, it suggested a possible favorable functional effect at 3 months in the least severe strokes, which could be the primary end-point for a future multicenter trial.