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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 (ClinicalTrials.gov: 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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