Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions

Carotid Plaques Clinical Trial

Official title:

Role of Vitamin K2 in the Reduction of the Calcium Content at the Level of the Carotid Bifurcation in Patients With Subcritical Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970084
• Other study ID #: PLAK2/74/OSR
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Ability to provide written informed consent

3. subjects with calcified lesions subcritical from the carotid bifurcation. with a range of 40-60% calculated method with ECTS (European Carotid Surgery Trial)

Exclusion Criteria:

1. Patients with reduced life expectancy or age> 80 years,

2. Patients already subjected to other clinical trial in the previous three months,

3. Patients with hypersensitivity or with known allergies to acetylsalicylic acid, patients with pre-existing mastocytosis, a history of asthma induced by salicylates, duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart failure, concomitant treatment with methotrexate, last trimester of pregnancy.

4. Patients with known hypersensitivity to vitamin K2 and vitamin D, people with hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia, nephrolithiasis and renal failure.

5. Uncooperative patients , or allergies related to the substance under study or with any contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the substances in the studio.

Related Conditions & MeSH terms

• Carotid Plaques

Intervention

Other:
• Nutraceutical product based on vitamin K2 (PLAK2)

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque		12 months