The use of menaquinone-7 in calcified carotid stenosis: a randomized double blind placebo controlled pilot study (SCAVIT-K2)

      Background and purpose: The carotid atherosclerosis is a condition related to a higher stroke risk. For this reason all preventive strategies are mandatory to reduce the probability of a cerebrovascular accident. Calcifications into a carotid plaque are present up to 60 % of all lesions and a stenosis over 50% in stroke patients without a calcified component is a rare condition. Menaquinone-7 has protective properties in reducing the level of arterial calcification. Aim of the study is to evaluate the efficacy of this molecule in reducing the calcified proportion of carotid plaque ( NCT01923012). Material and Methods: It was planned to recruit 100 cases without a previous history of stroke and with a calcified carotid stenosis under 70% and detected by a Doppler ultrasound (DUS) or CT angiography (CTA). Randomization method is 1:1 (drug : placebo) with the time ending of enrolment at February 2015. Demographic details, clinical and radiological data are collected. Particularly, carotid plaque morphology is assessed during the one-year follow up. Results: Until today 43 patients have been enrolled. Median age is 68 years and the main vascular risk factor is blood hypertension (80%). Median carotid stenosis is 55% with a median calcium volume score of 58.3 mm3. Conclusions: At the end of the present study we expect to observe a reduction of the carotid stenosis by a remodelling of calcified component in the menaquinone-7 treatment group.
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