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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01923012

Acronym

SCAVIT-K2

Enrollment

200

Registered

2013-08-14

Start date

2013-09-30

Completion date

2015-09-30

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Carotid Disease

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.

Interventions

DRUGVitamin K2 (Menaquinone)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Percentage reduction in plaque calcification and carotid stenosis	One year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026