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NCT01923012 Clinical Trial

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

Atherosclerosis Clinical Trial

— SCAVIT-K2  

Official title:
Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01923012
Other study ID # OSA-0001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received August 13, 2013
Last updated May 24, 2014
Start date September 2013
Est. completion date September 2015

Study information
Verified date May 2014
Source Azienda Ospedaliera Sant'Anna
Contact n/a
Is FDA regulated No
Health authority Italy: AIFA
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date September 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin K2 (Menaquinone)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera Sant'Anna

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage reduction in plaque calcification and carotid stenosis One year No
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