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

NCT ID: NCT02970084

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-05-31

Brief 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%.

Conditions

Carotid Plaques

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group with K2

The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months.

All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)

Group Type: EXPERIMENTAL

Nutraceutical product based on vitamin K2 (PLAK2)

Intervention Type: OTHER

Control group (no vitamin K2)

The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutraceutical product based on vitamin K2 (PLAK2)

Intervention Type: OTHER

Other Intervention Names

PLAK2

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scientific Institute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

yamume tshomba

Medical doctor Associate Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

San Raffaele Hospital

Milan, , Italy

Countries

Italy

Other Identifiers

PLAK2/74/OSR

Identifier Type: -

Identifier Source: org_study_id