Overview

Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

Status:
Unknown status
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Ospedaliera Sant'Anna
Treatments:
Vitamin K
Vitamin K 2
Vitamin MK 7
Vitamins
Criteria
Inclusion Criteria:

- carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque

Exclusion Criteria:

- 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