Phase II Randomized Placebo-controlled Study With Vitamin... | NCT01923012

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

NCT01923012

Sponsor

Azienda Ospedaliera Sant'Anna

Status

Unknown status

Last Update Posted

May 28, 2014Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Carotid Disease
Atherosclerosis

Interventions

Vitamin K2 (Menaquinone)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 13, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2014

Last Update Posted Date

May 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simone Vidale, Medical Doctor, Azienda Ospedaliera Sant'AnnaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Sant'AnnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Vitamin K2	Experimental		Drug: Vitamin K2 (Menaquinone)

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K2 (Menaquinone)	Drug		Vitamin K2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage reduction in plaque calcification and carotid stenosis		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D024482	Vitamin K 2

Ancestor Terms

ID	Term
D014812	Vitamin K
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided