Carotid DiseasePhase 2SCAVIT-K2NCT01923012
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
A Phase 2 study testing Vitamin K2 (Menaquinone) in people with Carotid Disease and Atherosclerosis, run by Azienda Ospedaliera Sant'Anna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carotid Disease, Atherosclerosis
- What is being tested?
- Vitamin K2 (Menaquinone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque
Who cannot join
- 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
About this study
Official title: Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
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.
- Conditions
- Carotid Disease, Atherosclerosis
- Being tested
- Vitamin K2 (Menaquinone)
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 (Menaquinone)Drug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2 | Experimental | Not described Receives: Drug: Vitamin K2 (Menaquinone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in plaque calcification and carotid stenosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Vidale, Azienda Ospedaliera Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923012
- Sponsor's protocol ID
- OSA-0001
- Acronym
- SCAVIT-K2
- Status last verified
- May 2014
- First submitted
- 13 Aug 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
- ClinicalTrials.gov ID
- NCT01923012
- Acronym / sponsor ID
- SCAVIT-K2 / OSA-0001
- Conditions
- Carotid Disease, Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Sant'AnnaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2 | Experimental | Drug: Vitamin K2 (Menaquinone) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque
Key exclusion criteria (8 listed)
- renal and/or hepatic failure
- diseases with secondary calcifications
- dementia
- previous strokes
- concomitant use of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2 (Menaquinone) | Drug | Vitamin K2 |
Primary outcome
Percentage reduction in plaque calcification and carotid stenosis
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin K2 (Menaquinone) in people with Carotid Disease and Atherosclerosis, run by Azienda Ospedaliera Sant'Anna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in plaque calcification and carotid stenosis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014; AzTrials last refreshed its copy on 29 Oct 2026.