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)
• Enrollment: 200
• Arm: 1
• Duration (Months): 24

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 Disease	Intervention/Treatment	Phase
Carotid Disease; Atherosclerosis	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

Arm	Intervention/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

• Additional relevant MeSH terms: Carotid Stenosis; Atherosclerosis; Vitamin K; Vitamin K 2

Study Results

No Results Posted as of May 28, 2014