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

Phase 2

• Conditions: Carotid Disease; Atherosclerosis
• Interventions: Drug: Vitamin K2 (Menaquinone)

• Registration Number: NCT01923012
• Lead Sponsor: Azienda Ospedaliera Sant'Anna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Study Start: 2013-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-05-28
• Primary Completion: 2014-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin K2	Vitamin K2 (Menaquinone)	-

Primary Outcome Measures

Name	Time	Method
Percentage reduction in plaque calcification and carotid stenosis	One year