PERFORM: Neutral Results in a Study of a Preventive Medication for Recurrent Stroke

Is the selective thromboxane–prostaglandin receptor antagonist terutroban noninferior to aspirin in preventing recurrent stroke? In this manufacturer-funded, international, randomized, double-blind study, 19,100 patients who had ischemic stroke in the previous 3 months or a transient ischemic attack in the previous 8 days received daily terutroban (30 mg) or aspirin (100 mg). The study was stopped prematurely, at a mean follow-up of 28 months, for futility.

The primary composite endpoint — ischemic stroke, myocardial infarction, or vascular death (excluding hemorrhage-related death) — occurred in 11% of each group. Furthermore, the treatment groups did not significantly differ on secondary or tertiary endpoints. In a subgroup analysis of patients with a previous ischemic stroke, the terutroban group had a significantly lower rate of the primary endpoint than the aspirin group (16% vs. 19%). The rate of minor bleeding was higher with terutroban, but the treatment groups showed no significant differences in other safety endpoints.