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

Azienda Ospedaliera Sant'Anna

Status and phase: Unknown; Phase 2

Conditions: Carotid Disease; Atherosclerosis

Treatments: Drug: Vitamin K2 (Menaquinone)

Study type: Interventional

Funder types: Other

Identifiers

NCT01923012

OSA-0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 1 patient group

Vitamin K2

Experimental group

Treatment:

Drug: Vitamin K2 (Menaquinone)