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

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ClinicalTrials.gov Identifier: NCT01923012
Recruitment Status : Unknown
Verified May 2014 by Simone Vidale, Azienda Ospedaliera Sant'Anna.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2013
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Simone Vidale, 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.

Condition or disease Intervention/treatment Phase
Carotid Disease Atherosclerosis Drug: Vitamin K2 (Menaquinone) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
Experimental: Vitamin K2 Drug: Vitamin K2 (Menaquinone)



Primary Outcome Measures :
  1. Percentage reduction in plaque calcification and carotid stenosis [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Simone Vidale, Medical Doctor, Azienda Ospedaliera Sant'Anna
ClinicalTrials.gov Identifier: NCT01923012     History of Changes
Other Study ID Numbers: OSA-0001
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Atherosclerosis
Carotid Stenosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants