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

Phase 2UnknownNCT01923012

Azienda Ospedaliera Sant'Anna200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Carotid Disease Atherosclerosis

Interventions

Vitamin K2 (Menaquinone)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage reduction in plaque calcification and carotid stenosis

Time frame: One year

Data from ClinicalTrials.gov

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