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

Primary Purpose

Carotid Disease, Atherosclerosis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vitamin K2 (Menaquinone)
Sponsored by
Azienda Ospedaliera Sant'Anna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vitamin K2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage reduction in plaque calcification and carotid stenosis

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2013
    Last Updated
    May 24, 2014
    Sponsor
    Azienda Ospedaliera Sant'Anna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01923012
    Brief Title
    Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
    Acronym
    SCAVIT-K2
    Official Title
    Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    September 2014 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera Sant'Anna

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Disease, Atherosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin K2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin K2 (Menaquinone)
    Primary Outcome Measure Information:
    Title
    Percentage reduction in plaque calcification and carotid stenosis
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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