Abstract
The Carotid Atherosclerosis Italian Ultrasound Study (CAIUS) is a multicenter double-blind, placebo-controlled randomized investigation of the effects of Pravastatin on progression of asymptomatic carotid atherosclerosis in outpatients with moderate hypercholesterolemia and without symptoms or signs of coronary heart disease. Intima-Media Thickness changes of the carotid arteries will be evaluated by B-mode ultrasound imaging. This method allows the detection and monitoring of early lesions and their evolution over time. The study involves approximately 305 patients with moderate hypercholesterolemia, and at least one asymptomatic and uncomplicated early carotid artery lesion. Randomized subjects are in the age range between 45 and 65 yrs. For women a natural or artificial menopause was mandatory. The subjects were randomized to receive either a placebo or an HMG CoA reductase inhibitor (Pravastin 40 mg OD), known to act selectively and primarily on liver cholesterol biosynthesis. The patient follow-up of CAIUS will have a duration of at least 36 months. Every 6 months participating subjects are being monitored by B-mode ultrasound as described in the protocol requiring training and certification of sonographers/readers and centralized reading. The study offers a unique opportunity to monitor the natural history of asymptomatic carotid lesions in hypercholesterolemic patients, as well as to evaluate the effect of a potent cholesterol-lowering medication on progression or regression of carotid atherosclerosis.
Published Version
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