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

Sponsor
Azienda Ospedaliera Sant'Anna (Other)
Overall Status
Unknown status
CT.gov ID
NCT01923012
Collaborator
(none)
200
Enrollment
1
Arm
24
Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Vitamin K2 (Menaquinone)
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2014
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

ArmIntervention/Treatment
Experimental: Vitamin K2

Drug: Vitamin K2 (Menaquinone)

Outcome Measures

Primary Outcome Measures

  1. Percentage reduction in plaque calcification and carotid stenosis [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azienda Ospedaliera Sant'Anna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simone Vidale, Medical Doctor, Azienda Ospedaliera Sant'Anna
ClinicalTrials.gov Identifier:
NCT01923012
Other Study ID Numbers:
  • OSA-0001
First Posted:
Aug 14, 2013
Last Update Posted:
May 28, 2014
Last Verified:
May 1, 2014

Study Results

No Results Posted as of May 28, 2014