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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Carotid Disease Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin K2

Group Type EXPERIMENTAL

Vitamin K2 (Menaquinone)

Intervention Type DRUG

Interventions

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Vitamin K2 (Menaquinone)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No