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Trial record 8 of 50 for:    vitamin k2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

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 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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Vitamin K
Vitamin K 2
Vitamin MK 7
Carotid Stenosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action