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

Not Applicable

Completed

• Conditions: Carotid Plaques
• Interventions: Other: Nutraceutical product based on vitamin K2 (PLAK2)

• Registration Number: NCT02970084
• Lead Sponsor: Scientific Institute San Raffaele

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Status Verified: 2019-05
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with K2	Nutraceutical product based on vitamin K2 (PLAK2)	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)

Primary Outcome Measures

Name	Time	Method
Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque	12 months

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milano, Italy