terutroban and Carotid-Stenosis

PERFORM is exploring the efficacy of terutroban versus aspirin for secondary prevention in patients with a history of ischemic stroke or transient ischemic attacks (TIAs). The PERFORM Vascular Project will evaluate the effect of terutroban on progression of atherosclerosis, as assessed by change in carotid intima-media thickness (CIMT) in a subgroup of patients.. The Vascular Project includes structural (CIMT, carotid plaques) and functional (carotid stiffness) vascular studies in all patients showing at least one carotid plaque at entry. Expected mean follow-up is 36 months. Primary endpoint is rate of change of CIMT. Secondary endpoints include emergent plaques and assessment of carotid stiffness. 1,100 patients are required for 90% statistical power to detect treatment-related CIMT difference of 0.025 mm. The first patient was randomized in April 2006.. The PERFORM Vascular Project will investigate terutroban's effect on vascular structure and function in patients with a history of ischemic stroke or TIAs.

Topics: Aged; Aged, 80 and over; Aspirin; Atherosclerosis; Carotid Arteries; Carotid Stenosis; Data Interpretation, Statistical; Double-Blind Method; Endpoint Determination; Epidemiologic Research Design; Female; Humans; Male; Middle Aged; Naphthalenes; Platelet Aggregation Inhibitors; Propionates; Quality Control; Reproducibility of Results; Sample Size; Stroke; Tunica Intima; Ultrasonography, Doppler, Duplex