UnknownPhase 2

Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

200 participantsStarted 2013-09

Plain-language summary

Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion Criteria: * carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque Exclusion Criteria: * renal and/or hepatic failure * diseases with secondary calcifications * dementia * previous strokes * concomitant use of anticoagulants * concomitant infections * pregnancy or breastfeeding * reduced patient's compliance

What they're measuring

Percentage reduction in plaque calcification and carotid stenosis

Timeframe: One year

Trial details

NCT IDNCT01923012

SponsorAzienda Ospedaliera Sant'Anna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

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