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OpenTrials
Completed

NCT Number: NCT02970084

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

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%.

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Key information

Conditions

Carotid Plaques

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Ability to provide written informed consent
  • 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

  • Patients with reduced life expectancy or age> 80 years,
  • Patients already subjected to other clinical trial in the previous three months,
  • 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.
  • 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.
  • 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.

Treatment and study plan

Nutraceutical product based on vitamin K2 (PLAK2)

Other

Other names: PLAK2

Primary outcomes

  1. Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2016
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.